Engineering Jobs in Alameda County, CA

Senior Project Manager – Design and Construction Services

The Design and Construction Services (DCS) group is seeking a Senior Project Manager to deliver world-class design and construction of facilities and infrastructure projects in support of world-changing scientific research. The Senior Project Manager will be responsible for planning, developing, procurement, design, construction, and close-out/transition to operations of project scopes ranging from $1M to $200M. The organization currently has multiple ongoing projects to improve scientific research capabilities and to maintain existing infrastructure, including backbone utility systems and experimental spaces such as research laboratories, cleanrooms, and associated MEP systems.

The Senior Project Manager could be assigned to one major project (>$30M) or several minor projects. Major projects include Department of Energy line-item projects such as critical utilities infrastructure revitalization and large-scale research facility upgrades. Minor projects include a wide range of infrastructure improvements such as electrical distribution system repairs and upgrades, cooling tower replacements, roadway repairs, and pipeline/culvert repair and replacements.

When serving on a major project, the Senior Project Manager is accountable to the Project Director or Infrastructure System Manager. When serving on minor projects, the Senior Project Manager is accountable to the Project Management Manager. The Senior Project Manager carries responsibility and authority for planning, coordinating, and executing critical project scopes to ensure the project's mission and program are met in terms of technical scope, cost, schedule, and resources.

The successful candidate will liaise with a broad range of organizational groups and stakeholders, including scientists, physicists, operations and engineering teams, finance and contracting, facilities maintenance experts, and project managers of other systems. The Senior Project Manager is also responsible for coordinating the engineering and design process, overseeing A/E service design contracts and construction contracts during construction, and presenting project information to DOE in Project Reviews, Project Assurance and Advisory Group meetings, and regular monthly meetings attended by senior leaders.

Your specific responsibilities include:

• Primary focus will be on delivering electrical, mechanical, and civil infrastructure design and construction work scopes of assigned major or minor project(s).
• Perform the full range of project management cycle on assigned project control accounts, including initiating, planning, executing, monitoring, controlling, and closing of all responsible WBS activities. Independently lead and direct work scopes and deliverables involving functional integrations with multiple engineering systems and disciplines.
• Develop and manage critical paths and schedules. This position requires detailed knowledge of project schedule, with a high level of awareness of interdependencies with other major projects' schedules and operation downtimes. Develop and maintain a project baseline.
• Manage projects to ensure deliverables are met within cost, schedule, and technical expectations.
• Direct development of project execution plan, communication plan, and acquisition strategy plans. Responsible for development of a resources plan for assigned project control accounts, including level of effort for management, supporting labor, materials, and time required to complete assigned project control accounts.
• Facilitate discussions and negotiations between stakeholders to drive consensus on project design and operation requirements.
• Perform technical oversight of the project. Direct the work of contractors and Architects/Engineers consultants to successfully complete assigned project control accounts. Ensure that project requirements are captured and the design meets program requirements as established by project stakeholders and approved project documentation. Develop and maintain project documentation.
• Organize and prioritize the work of the project team.
• Utilize approved project management systems, processes, and tools during design and construction to ensure alignment with the Project Portfolio Management Office's and DOE's reporting requirements from an overall Project Status and Quality Assurance perspective. Ensure the use of standard DOE O 413.3B project management tools.
• Organize and hold design readiness and technical reviews. Identify and manage responsible project accounts' risks and actively monitor mitigation measures to control cost, schedule, and scope. Identify and manage project risks and make critical decisions.
• Integrate Environmental Safety & Health (ES&H) considerations in planning, design, and construction of facilities. Ensure implementation of ES&H policy and best practices in construction. Ultimately responsible for general contractor activities such as safety, configuration, cost, and schedule control on assigned project control accounts. Execute the project in compliance with the National Environmental Policy Act (NEPA) and other applicable ES&H rules and regulations.
• Establish staffing needs and facilitate project resource requests.
• Foster a culture of safety and respect.
• Ensure that construction conforms to organizational policies and engineering specifications under very dynamic working conditions.
• Interact with DOE Site Office representatives along with the Project Director or Infrastructure System Manager to convey project status and proactively communicate challenges as they arise.
• Other duties as assigned.

To be successful in this position you will bring:

Bachelor's degree in Electrical, Mechanical, or Civil Engineering, Architecture, Construction Management (with a focus on infrastructure projects), or related field and at least 5 years of work experience, with 7 to 9 years preferred. At least 3 years of experience serving as a project leader with direct responsibility of at least $10M of scope and direct experience in:

• Providing project management and leadership on delivering major electrical, mechanical, and civil infrastructure scope of mission-critical projects with complex engineering design, extensive interfaces, and restricted construction work windows.
• Delivering construction projects using design-build, design-bid-build, and CM/GC methods.
• Overseeing single contract procurement of over $10M, from the sources sought phase through RFP development, vendor selection and contract negotiations, contract award and vendor performance management, change control, and contract closeout phases.
• Utilizing Primavera P6, MS Project, AutoCAD, Revit, Bluebeam, SharePoint, or other software to enhance collaboration during design review, control and streamline design and construction processes, and reduce construction conflicts and schedule uncertainty.
• Utilizing AACE estimate classifications, design maturity, and risk assessments to develop cost and schedule contingency.
• Highly effective written and oral communication skills to address a wide variety of audiences and convey complex technical information and project objectives to clients, Authority Having Jurisdiction (AHJ), construction contractors, architects and engineers, and financial and contracting personnel. Ability to maintain positive interpersonal relationships, balance customer expectations with project reality, and successfully guide decision-making to achieve project goals and deadlines.
• Strong commitment to improving construction quality and safety by investing in front-end planning, applying safety by design principles, embracing peer review processes, and actively sharing and applying lessons learned.
• A can-do spirit and demonstrated resilience, respect, and practical problem-solving skills under stressful and uncertain situations. A passion for doing it right the first time.

Preferred qualifications include:

• Master's degree or MBA a plus.
• Working knowledge in implementing project management practices required by DOE Order 413.3 Program and Project Management for Acquisition of Capital Assets, to include project planning, budgeting, scheduling, cost estimating, risk management, and performance management.
• Experience with Earned Value Management Systems in a project and/or construction environment.
• Experience managing multi-year public-funded construction projects subject to Federal Acquisition Regulation (FAR).
• Knowledge of California Building Codes, electrical and mechanical design standards, local environmental standards and practices, and industrial and construction safety standards.
• Familiarity with design and construction of high-voltage and medium-voltage electrical transmission and distribution systems as well as electrical SCADA systems.
• Familiarity with sustainable design and construction approaches to reduce a project's carbon footprint.

Certifications and Licenses:

• Valid driver's license required. This position requires driving a personal or company vehicle to/from and safely on a construction work site.
• Professional Engineer (PE) license or Registered Architect (RA) preferred.
• Project Management Professional (PMP) certification a plus.

Top Skills:

Full cycle recruiting.

Offer Negotiation and driving closures.

In-house and Agency Experience.

Job Title: Technical Recruiter III

Location: SFO, CA (Hybrid)

Duration: 06+ months

Description:

You'll be tasked with supporting our hiring managers, building high-performance teams and partnering wherever needed.

- You will source and hire across all teams but primarily engineering; helping to drive our product and ultimately continue to expand our business globally.

- You will create robust pipelines while making each candidate feel like they're the only one you're talking to.

- You will be knowledgeable about our business and be on point for HR related questions (i.e. benefits, comp, etc).

- You will spread the Uber LOVE through attending networking events, e-meetups, etc.

- You will work to improve upon existing programs and develop innovative strategies around finding our future team.

- You will develop relationships across multiple teams.

- You will showcase your passion for the industry. That means intimate knowledge about market, target companies, relationships in open source networks.

- You will willingly build pipelines from scratch, over and over again.

What you'll need

- At least 5 years of technical recruiting experience required

- At least 1 year of technical sourcing experience required

- In-house & agency recruiting experience

- To be degreed or have equivalent work experience

- To be technically savvy

-Full cycle recruitment

-Offer Negotiation and driving closures.

Investment Director - American Housing Company

Location: Oakland, CA (on-site)

About oWOW

oWOW is a vertically integrated real-estate development firm on a mission to accelerate housing abundance. By unifying design, prefab construction, and development under one roof—and pioneering mass-timber, modular methods—we deliver beautiful, sustainable housing faster (2X) and at a substantially lower cost than traditional builders.

Role Overview

As an Investments Director you will be the financial/acquisition engine behind our growing development pipeline, leading deal sourcing, underwriting, and capital raising. Reporting to the CEO, you will shape strategy, source sites, build out the team, and build investor relationships, driving transactions from LOI through closing.

Key Responsibilities

● Deal Sourcing & Underwriting – Build a statewide first then nationwide broker network, identify sites, and produce institutional-grade pro formas and feasibility models.

● Project Financing – Draft RFPs, market opportunities to lenders and equity partners, negotiate term sheets, and shepherd closings.

● Capital Markets – Create and update investor decks, raise pre-development equity, and cultivate programmatic funding partnerships.

● Transaction Management – Manage due diligence, coordinate consultants, and keep multiple deals on schedule.

● Process & Data – Standardize underwriting models, maintain a site/investor CRM, and deliver weekly pipeline reports.

● Hire and Build the team – Create an org chart, scorecards for each role, budget and then get to work on hiring the best and brightest.

First Year Outcomes

1. Finance Phase 1 LIHTC Projects – Issue RFP packages within a week of award announcements and close debt/equity on 6-8 projects by year-end.

2. Secure Phase 2 Pipeline – Source 200+ sites, fully underwrite priority targets, option at least 20 sites.

3. Raise Pre-Dev Equity – Assist on raising pre-development capital for projects as well as from project partners.

4. Institutionalize Underwriting – Implement standardized models and a live database of sites and investors within 90 days.

Requirements

● 5+ years in real-estate finance, acquisitions, or development; multifamily and LIHTC experience strongly preferred.

● Advanced financial modeling and deal-structuring skills.

● Desire to work extremely hard and believer in meritocracy

● Excellent communication, project-management, and relationship-building abilities.

● First Principles thinking

Compensation & Benefits

● Competitive salary + performance bonus

● Promote in Projects

● Ability to invest

Logistics & Warehouse Planner

Job Description

The Logistics & Warehouse Planner is responsible for coordinating material flow, warehouse activities, and inventory levels across multiple projects. You’ll work closely with warehouse leads, production teams, purchasing, and suppliers to ensure materials are available when needed—avoiding shortages, delays, or inefficiencies.

Job Summary

You’ll plan and schedule deliveries, oversee warehouse allocation, track inventory levels, and align purchasing expectations to maintain a steady flow of materials throughout the operation. As a central point of communication between warehouse operations, suppliers, carriers, and internal teams, you will manage inquiries, delivery updates, schedule changes, and cancellations while keeping communication clear and consistent.

Essential Functions

Determine required materials based on production schedules and warehouse stock levels.

Generate RFQs, purchase orders, and replenishment requests as needed.

Ensure incoming materials meet specifications, quality requirements, and cost standards.

Maintain accurate inventory records and ensure consistent supply to support daily operations.

Coordinate cross-department communication on inventory needs, delivery timelines, and supplier payments.

Track warehouse throughput, inbound/outbound volumes, and material usage trends.

Schedule and oversee the receipt, storage, staging, and delivery of materials and finished goods.

Liaise with suppliers, distributors, carriers, and internal teams regarding logistics and warehouse requirements.

Manage inventory discrepancies, schedule changes, and order cancellations.

Prepare cost estimates, inventory forecasts, KPIs, and operational performance reports.

Essential Requirements

Ability to analyze demand forecasts, warehouse capacity, and material consumption.

Experience generating RFQs, purchase orders, replenishment schedules, or logistics documentation.

Knowledge of warehouse operations, material compliance, inventory control, and cost management.

Strong organizational, communication, and problem-solving skills.

Ability to prioritize tasks and work in a fast-paced environment.

Other Functions

Collaborate with quality control to ensure incoming and outgoing materials meet company standards.

Identify warehouse bottlenecks, improve material flow, and support continuous improvement initiatives.

Monitor market trends, supplier performance, and customer needs to adjust inventory strategies.

Support cycle counts, physical inventory, and warehouse audits.

Job Requirements

Bachelor’s Degree in Supply Chain, Logistics, Operations Management, Business, Industrial Engineering, or related field (or equivalent experience).

Prior experience in logistics planning, warehouse coordination, or inventory management preferred.

Job Type: Full-time

Be part of the future of transportation!

Continuum is partnering with a leading autonomous ride-hailing company developing next-generation robotaxi technology, and we’re hiring Level 3 Vehicle Operators in San Francisco, CA, to support real-world vehicle testing and operations. This role puts you on the front lines of autonomous mobility, working with cutting-edge technology that will redefine how people move through cities.

If you have professional driving experience and enjoy working with technology and troubleshooting systems, this is a unique opportunity to break into the rapidly growing autonomous vehicle industry.

Experienced AV Operators are also encouraged to apply to expand their experience working with advanced self-driving systems.

WHAT YOU'LL DO:

As an Autonomous Vehicle Operator, you will support daily testing and operations of autonomous vehicles while helping ensure the highest standards of safety and operational excellence.

Key responsibilities include:

• Safely operating autonomous test vehicles 4–8 hours per day
• Supporting vehicle testing, data collection, and operational missions
• Conducting basic software and system troubleshooting tasks
• Providing clear written and verbal feedback to engineering teams
• Assisting with vehicle readiness and preventative maintenance checks
• Supporting vehicle logistics, movement, and storage
• Ensuring vehicle cleanliness, readiness, and workplace organization
• Documenting operational metrics and observations
• Acting as a brand ambassador when interacting with the public

You’ll collaborate with teams across the company including:

• Autonomous Systems Engineering
• Computer Vision
• Vehicle Engineering
• Infrastructure
• Ride Operations
• Strategy and Product

WHAT WE'RE LOOKING FOR:

The ideal candidate is safety-focused, disciplined, detail-oriented, and comfortable working in a fast-paced technology environment.

Preferred qualifications:

• Experience troubleshooting technology or technical applications
• Professional driving experience (rideshare, delivery, military, public transit, etc.)
• Ability to remain focused during extended driving periods (up to 6 hours/day)
• Basic vehicle knowledge and the ability to perform vehicle checks
• Strong written and verbal communication skills
• Proactive mindset and strong problem-solving ability
• Excellent driving history and clean background
• Military experience is a plus
• Candidates who enjoy technology, robotics, mobility innovation, or automotive systems tend to thrive in this role.

SCHEDULE:

Monday – Friday

Morning Shift: 7:45 AM – 4:15 PM

Evening Shift: 3:45 PM – 12:15 AM

Shift Bonuses:

• +5% hourly pay for weekend shifts
• +5% hourly pay for evening shifts starting at 3:30 PM or later
• Up to +10% additional pay for weekend evening shifts

BENEFITS:

• Employer-subsidized healthcare coverage
• Pre-tax commuter benefits
• Flexible Spending Account (FSA)
• Short- and long-term disability coverage
• Life insurance
• 401(k) retirement plan
• Paid Time Off and Sick Leave

San Francisco, CA

You love to tackle problems and build solutions. When intrigued by an idea, you focus your energy and dedicate your mind to learn everything you can about it, quickly! Then, you figure out how to apply what you've learned to the issue at hand and propel it forward. Facing big challenges head on inspires you. You chart the process and you own the outcome. You love helping people. You enjoy sharing knowledge and get energized by smart people navigating complicated problems together. Reaching milestones motivates you. You're an early riser. And, you're ready for your next adventure.

We are on a simple, yet daring mission: revolutionize the modern procurement software industry, and, dare we say make it delightful. Delightful procurement.

Founded in 2022, Levelpath is a mobile-first platform that's powered by AI. We believe in software that's thoughtfully engineered to solve problems and drive progress. The opportunity is huge, as the procurement market today is $11.5 billion and it's growing quickly. Our founding team has a track record of building successful companies, and we're backed by visionary Silicon Valley venture capital firms. We're focused on delivering delightful user experiences to all stakeholders. Our vision is to future-proof our customers' procurement function, and make enterprises of any size faster, safer, and more transparent.

We're looking for a Customer Support Specialist to join our team. Reporting into Product, you will not only get a front row seat to what it takes to scale a successful product from the early days, but you will play a critical role in developing strong relationships with our customers and users, and advocating on their behalf to continuously improve our platform.

We are building a world class support team obsessed with helping our customers, and focused on getting them back on the right path when challenges arise. This is a rewarding opportunity to drive meaningful impact and build from the ground up alongside a leadership team passionate about making a difference in the procurement world.

This position is located in downtown San Francisco, in-office, conveniently adjacent to public transit. While a startup, we offer most standard benefits you'd expect from a mature organization - even transportation and 401k! You'll be a part of a spirited international team, in an agile environment with short decision paths and quick delivery. You may leverage any devices and tools that allow you to do your best work.

• Drive impact by focusing on customer experience. Examples of day-to-day activities include answering support tickets, providing users guidance when they are stuck, generating product documentation, reporting bugs to product & engineering, and numerous other related jobs.
• Be the first touch point for users encountering difficulties with the product and a reliable resource to resolve their questions and issues
• Learn the intricacies of a cutting edge enterprise product and be a Levelpath product expert for our customer base to drive product adoption and satisfaction
• Interact directly with Product and Engineering teams to identify areas where we can better serve our customer base
• Build best practice guides and playbooks to ensure our customers and their users are set up for success
• Act as a trusted advisor & support customer health by understanding their users' friction points when using Levelpath
• You will have a seat at the table and partner with our executive team - helping to build, optimize, and scale our processes, assets, & systems (Zendesk & Salesforce)

• Empathy, patience, and a sense of urgency when supporting customers
• 4-6 years of experience in a customer-facing/customer-management role
• B2B SaaS experience in a fast-paced environment
• BA or BS
• Demonstrated experience problem-solving with attention to detail
• Stellar organizational skills and experience improving processes
• Strong written and verbal communication skills
• Adaptability and ability to flourish in a fast-paced environment
• Comfort in managing multiple workstreams
• Ability to communicate with stakeholders across product and engineering
• Effective collaboration and self-starter mindset
• Availability for some travel - when the time comes to visit your customers!

• 100% Medical, dental, and vision insurance
• Flexible PTO, Parental Leave, Sick Leave
• Competitive compensation and equity package
• 401k
• Commuter benefits
• In-office snacks and Friday team lunches
• Team-driven happy hours and celebrations

The estimated annual cash salary for this role is $62,000- $120,000. Levelpath is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment. We work hard to evaluate all employees and job applicants consistently, without regard to race, color, religion, gender, national origin, age, disability, pregnancy, gender expression or identity, sexual orientation, citizenship, or any other legally protected class. We're working to build a more inclusive economy where our customers have equal access to opportunity, and we strive to live by these same values in our workplace.

Crusoe is on a mission to accelerate the abundance of energy and intelligence. As the only vertically integrated AI infrastructure company built from the ground up, we own and operate each layer of the stack from electrons to tokens to power the world's most ambitious AI workloads. When you join Crusoe, you join a team that is building the future, faster.

We're in the midst of the greatest industrial revolution of our time. The demand for AI compute is boundless, and power is a bottleneck. We're solving that with an energy-first approach that makes AI infrastructure better for the world and faster for the people innovating with AI.

We're looking for problem-solving, opportunity-finding teammates with a sense of urgency, who believe in the scale of our ambition and thrive on a path not fully paved people who want to grow their careers alongside a team of experts across energy, manufacturing, data center construction, and cloud services.

If you want to do the most meaningful work of your career, help our customers and partners advance their AI strategies, and be part of a high-performing team that believes in each other, come build with us at Crusoe.

As part of our continued expansion, we're hiring a Construction Cost Estimator to drive cost modeling and financial accuracy across our capital projects. This role plays a critical function in delivering predictable outcomes by pairing detailed cost estimation with proactive cash flow forecasting to support Crusoe's global growth.

• Lead end-to-end estimating efforts for data center buildsfrom early-stage planning through construction execution
• Develop robust cost models that align with design intent, scope evolution, and delivery strategies Collaborate with design, procurement, and delivery teams to validate quantity take-offs and unit pricing
• Build and maintain project cash flow forecasts to support financial planning, budget tracking, and funding requests
• Provide detailed estimates for CSA, MEP, and mission-critical systems for domestic and international builds
• Evaluate vendor and subcontractor proposals against internal benchmarks and historical data
• Analyze variances and model cost impacts due to design changes, procurement risks, or schedule shifts
• Partner with finance, real estate, and development teams to inform business cases and funding strategy
• Deliver concise cost reports, dashboards, and executive summaries with clear insights and recommendations
• Establish scalable tools and repeatable processes to support Crusoe's infrastructure pipeline
• Maintain historical cost databases and continuously refine models based on actuals and market trends
• Contribute to site feasibility assessments and preconstruction planning with data-backed insights
• Support value engineering exercises and cost optimization strategies

• Bachelor's degree in Construction Management, Engineering, Quantity Surveying, or related field
• 10+ years of experience in construction cost estimating for complex infrastructure projects
• Strong experience in cost modeling, budgeting, and cash flow forecasting
• Deep technical knowledge of MEP, CSA, and mission-critical systems
• Expertise with estimating software such as CostX, Sage Estimating, or equivalent
• Ability to translate technical and financial inputs into actionable reporting
• Strong communication skills with experience presenting to both technical and executive stakeholders
• Willingness to travel up to 25%, including international locations
• Background with general contractors, owner's rep firms, or tech/data center infrastructure
• Familiarity with the full construction lifecycle including preconstruction, procurement, and delivery
• Experience with Lean methodologies, design-build, or integrated project delivery
• Advanced degree or certifications such as AACE, RICS, or CMAA

• Competitive compensation
• Restricted Stock Units
• Paid time off & paid holidays
• Comprehensive health, dental & vision insurance
• Employer contributions to HSA account
• Paid parental leave
• Paid life insurance, short-term and long-term disability
• Professional development & tuition reimbursement
• Mental health & wellness support
• Commuter benefits (parking & transit)
• Cell phone stipend
• 401(k) Retirement plan with company match up to 4% of salary
• Volunteer time off

Compensation will be paid in the range of up to $154,000 - $188,000 + Bonus. Restricted Stock Units are included in all offers. Compensation to be determined by the applicants knowledge, education, and abilities, as well as internal equity and alignment with market data.

Crusoe is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, disability, genetic information, pregnancy, citizenship, marital status, sex/gender, sexual preference/ orientation, gender identity, age, veteran status, national origin, or any other status protected by law or regulation.

This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required.

Essential Duties And Responsibilities:

• Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance.
• Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities
• Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities.
• Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs)
• Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance
• Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization
• Represents CQA in internal presentations on quality issues, initiatives, and projects
• Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner.
• Participates in identifying and implementing process and system improvements

Supervisory Responsibilities:

None

Education/Experience/Knowledge & Skills:

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or,
• Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or,
• PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Minimum of 10 years relevant experience in pharmaceutical and biotech industries.
• Experience in Good Clinical Practices highly desired
• Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes
• Strong understanding of Quality Risk Management
• Experience using standard MS Office

Knowledge/Skills:

• Understanding of the drug development process, particularly related to QA oversight of clinical trials
• Experience in assisting in the development of business strategies, metrics, and continuous improvements
• Working knowledge of Health Authority rules and regulations
• Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP.
• Ability to apply Quality Risk Management in a variety of situations across Quality Systems
• Ability to influence others as part of a collaborative team and negotiate effective solutions
• Strong interpersonal and social skills
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Detail-oriented in execution of tasks and processes
• Implements technical solutions within quality requirements to complex problems.
• Excellent verbal and written communication skills
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Provides insight and analysis of situations or data requires a review of a variety of factors.

Working Conditions:

• Environment: primarily working in laboratories or in office
• Infrequent travel may be required.

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $153,500 - $217,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

• Shape enterprise-wide QA/QC/QE strategy in a high-visibility leadership role
• Lead inspection readiness and partner directly with FDA/EMA
• Build and scale a high-performing Quality organization
• Influence antibody development, biologics manufacturing, and tech transfer
• Competitive salary, strong benefits, and onsite leadership visibility
  
  

• Driving Quality strategy, systems, and culture
• Leading QA/QC/QE teams and quality operations
• Managing audits, compliance, and regulatory interactions
• Overseeing QMS, CAPA, deviations, document control
• Supporting CMC, manufacturing, and client-facing quality needs
  
  

• 15+ years QA in pharma/biopharma; 5+ years leadership
• Extensive GxP and global regulatory expertise
• CDMO or biologics background preferred
• Strong communicator and cross-functional partner
  
  

Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation.

We are currently seeking a highly motivated and detail-oriented VP of Quality and Compliance to join our team in the mission to restore vision to patients. This role will report to the Chief Development Officer

The selected candidate will work closely with our Clinical and CMC teams and establish the Quality Department. The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and/or Quality Control functions. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require 15-20% domestic travel to our contract development and manufacturing organizations in the United States.

Position Overview:

The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and Quality Control functions. They are responsible for leading all quality control systems, regulatory compliance, and safety, ensuring products/services meet industry standards. They are responsible for clinical and CMC quality requirements, vendor management, internal and external compliance, and ensuring that AAV drug substance and product manufacturing, testing, and release meet FDA, EMA, and ICH regulatory standards, from clinical stage to commercialization.

The Vice President of Quality will establish, lead and develop the quality function, in line with the company's stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment.

Essential Duties and Responsibilities:

• Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical CROs and CMC CDMO’s
• Maintain efficient systems and processes that ensure RayTx and its vendor network comply with GXP standards
• Ensure the appropriate identification, evaluation, and management of risks associated with quality
• Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations
• Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle
• Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues
• Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations
• Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP activities
• Prior experience establishing a Quality Department and growing a group.
• Strong knowledge and understanding of clinical trial design.
• Quality Management System (QMS) Oversight:Develop, implement, and maintain robust quality systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions).
• Provide expert quality oversight on AAV manufacturing processes, analytical method validations, and comparability studies.
• Prior experience developing GCP / GMP auditing plans.
• Regulatory Compliance: Ensure site compliance with global regulations (FDA, EMA) and lead audit readiness efforts (internal and external inspections).
• Batch Disposition: enact internal quality reviews of GMP batch records, and management of finalization and release of clinical or commercial AAV vectors.
• Vendor Management: Oversee quality agreements and audits for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CRO’s).
• Team Leadership: Mentor and lead quality personnel, fostering a culture of quality, safety, and operational excellence

Qualifications and Experience:

• Minimum bachelor's degree in relevant scientific or engineering discipline.
• 8+ years relevant biotech experience.
• Experience in GMP AAV gene therapy manufacturing preferred.
• Knowledge of AAV analytical methods and testing preferred.
• Experience working with CDMO, CRO’s, and other external vendors preferred.
• Experience with clinical quality oversight, SOP generation
• Experience with vendor management and audit planning
• Excellent scientific knowledge and acumen.
• Familiarity with regulatory requirements and documentation
• Ability to travel up to 20%

Compensation Range and Benefits:

• The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.