Jobs in Garner

Job Summary

The Director / Senior Director / Executive Director, CMC Regulatory Affairs is responsible for leading global regulatory CMC development, registration, and compliance activities from early development through commercialization. This role reports to the Head of Global Regulatory Affairs and may be based on-site or remote, depending on organizational needs. The position plays a critical role in defining and executing global CMC regulatory strategies in alignment with business and development objectives.

Key Responsibilities

Regulatory Strategy & Leadership

• Lead the development and execution of global CMC and device regulatory submission strategies in close collaboration with cross-functional project teams.
• Review CMC content and manage submission timelines to ensure alignment with business objectives.

Regulatory Compliance & Guidance

• Assess and communicate global CMC and device regulatory requirements to ensure development activities comply with applicable regulations and guidelines.
• Maintain current knowledge of evolving global CMC and device regulatory regulations, standards, and guidance, and communicate impact to stakeholders.

Quality by Design (QbD) & Risk Management

• Partner with CMC and technical teams to develop and document Quality by Design (QbD) strategies for novel manufacturing processes.
• Conduct risk assessments and develop mitigation strategies for global CMC and device regulatory matters.

Regulatory Submissions & Agency Interactions

• Lead preparation and review of CMC sections for regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, supplements, annual reports, amendments, and regulatory correspondence.
• Prepare and coordinate responses to regulatory authority information requests during application review and post-approval maintenance.
• Serve as a primary regulatory interface with health authorities on CMC and device-related matters, including leading preparations for regulatory agency meetings.

Manufacturing & Inspection Readiness

• Collaborate closely with Manufacturing, Quality, and external partners to support GMP facility inspections and regulatory audits.
• Assess CMC-related and device changes and ensure timely and compliant reporting to global health authorities.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality, R&D, and external vendors to support development programs, commercialization activities, and lifecycle management.
• Communicate complex CMC strategies, novel manufacturing processes, and QbD activities clearly and effectively to internal stakeholders and regulatory agencies.

Education & Experience

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, Life Sciences, or a related discipline required; advanced degree preferred.
• RAC or similar regulatory certification is a plus.
• Minimum experience requirements by level:
• Director: 10+ years of CMC regulatory or related pharmaceutical industry experience
• Senior Director: 12+ years
• Executive Director: 15+ years
• Demonstrated ability to define and execute global CMC regulatory strategies with minimal oversight.
• Strong understanding of drug development and lifecycle management, including interdependencies across functions.
• Small molecule experience preferred.
• Experience with pharmaceutical Quality by Design (QbD) concepts and implementation.
• In-depth knowledge of FDA and ICH regulations and guidelines, with experience serving as an FDA liaison; familiarity with EU and other global regulatory requirements preferred.
• Proven experience authoring and submitting INDs, CTAs, IMPDs, NDAs, MAAs, and supplements.
• Experience supporting post-market and commercialization CMC regulatory activities.

ABOUT THE CLIENT - Healthcare

A well-established commercial general contractor with decades of industry experience, delivering comprehensive construction services across multiple states along the eastern seaboard. The company is committed to building long-term relationships with clients, employees, and partners, and has a strong reputation for successfully delivering high-quality projects in the healthcare, and education sectors. Projects range from mid-sized renovations to large-scale ground-up developments valued between up to $80m (Ground up / Renovation)

ABOUT THE ROLE

• Oversee and manage all on-site construction activities from pre-construction through project closeout
• Execute and maintain detailed project schedules and budgets for projects ranging from $20M–$100M
• Coordinate with engineers, architects, subcontractors, inspectors, and suppliers to meet project requirements and proactively resolve issues
• Review plans, specifications, and contract documents to ensure compliance with project objectives and quality standards
• Lead by example in enforcing safety standards, policies, and procedures
• Foster and maintain strong relationships with clients, team members, and project partners
• Attend and actively participate in project meetings
• Prepare and submit regular progress, budget, and safety reports
• Experience with ground-up and renovation projects in Retail, Healthcare, and Education environments

ABOUT THE CANDIDATE

• Minimum 5 years of experience in field construction management as a Superintendent
• Proven experience delivering Healthcare, and/or Education construction projects valued between $20m–$100M
• Strong leadership, organizational, and team management skills
• Solid understanding of scheduling, budgeting, and quality control processes
• Excellent verbal and written communication skills
• Proficient in Microsoft Office and relevant construction management software

The Associate Dean works closely with other members of the College Counseling department to design engaging learning opportunities for Saint Mary’s students so they can more effectively and confidently navigate the college search and application process. Additionally, the Associate Dean is a lifelong learner with a growth mindset who stays current with the landscape of college admissions.

They are looking for someone that has 5 - 7 years' experience in College Counseling in HS settings. It would be a plus if they have worked in international schools and or have experience working in an all-girls or private school environment.

Responsibilities

As part of a highly collaborative team reporting to the Dean of College Counseling, the Associate Dean will:

• Counsel, support, and guide a diverse group of approximately 25-30 students in each class through academic planning and the college search and application processes.
• Maintain expertise in understanding the complexities of college admission and guide students with a supportive, optimistic, and thoughtful approach.

Requirements

• A Bachelor’s degree is required, advanced degree is preferred.
• Five or more years of experience in college counseling at a secondary school level or in college admissions. Candidates with an equivalent combination of education and school/counseling experience may also be considered.

Salary around $75,000 (Up to 100K for the right candidate) with maybe an option of housing if they have any available

POSITION DESCRIPTION

POSITION TITLE: System Administrator I

DEPARTMENT: Information Technology

REPORTS TO: IT Manager

JOB SUMMARY:

Under the guidance of the IT Manager or Team Leader, System Administrators independently ensure the smooth operation of computer systems and servers. They handle hardware and software installations, user administration, engage in research to align with the organization's evolving IT needs, and proactively address system issues to minimize disruptions. Their role encompasses designing, documenting, maintaining, and overseeing the core enterprise system/network as per industry standards. They oversee and serve as the main point of contact for helpdesk support.

DUTIES AND RESPONSIBILITIES:

• Provide primary helpdesk support, ensuring SLA adherence for ticket priority.
• Perform desktop and helpdesk support, ensuring timely resolution with minimal disruption.
• Escalate business-impacting issues to management.
• Handle employee onboarding and offboarding.
• Compile documentation for system and application support.
• Contribute to the reliability and configuration of computer systems, servers, and virtualization.
• Upgrade computer hardware/software, perform limited virtual server administration, and enforce best practices for OS and hardware management.
• Oversee user equipment deployment and replacement process.
• Diagnose hardware/software errors, documenting resolutions and assessing issue impact.
• Provide technical specifications for IT projects and maintain system administration policies and training.
• Research and recommend IT infrastructure improvements.
• Collaborate with third-party vendors and in-house teams.
• Uphold system security and business continuity.
• Participate in an on-call rotation.
• Maintain asset inventory.
• Respond to alerts and resolve them efficiently.
• Provide Audio/Video support during meetings.

OTHER DUTIES:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Computer Science, Information Technology, System Administration, or a closely related field.
• At least three years of system administration hands on experience with the following technologies is strongly preferred:
• Windows Operating Systems (server and client), Office 365, VMWare, Identity Management, Windows Operating Systems, Cisco Networking, Phone system, VPN, Multifactor authentication, Endpoint protection, Cloud infrastructure.
• An equivalent combination of education and experience may be substituted.

REQUIRED SKILLS AND ABILITIES

• Proficiency in systems, networking software/hardware
• Expertise in helpdesk and IT operations best practices, with deep knowledge in security, data protection, and disaster recovery.
• Outstanding problem-solving, communication, and documentation aptitude.
• Effective communication with all levels of the organization.
• Ability to handle high-pressure situations and make timely decisions.
• Collaborative proactive approach to contributions and discussions.
• Certifications in Linux and Microsoft technologies are helpful.
• Ability to work flexible hours.

PHYSICAL REQUIREMENTS

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job:

• Dexterity of hands and fingers to operate a computer keyboard, mouse, and other related devices.
• Ability to work in the office as required, which may include up to five days or more per week, based on operational needs.
• Ability to sit at a desk using a computer for extended periods.
• Physical ability to participate in training sessions, presentations, and meetings.

Why start your new career with flyExclusive:

FlyExclusive is a dynamic and growing company with a strong commitment to safety, service, and excellence. As a member of our team, you will have the opportunity to work with state-of-the-art aircraft and advanced technologies, providing you with valuable experience and career development opportunities. We offer a competitive salary and benefits package, as well as a supportive and collaborative work environment. Join us at flyExclusive and take your career to new heights!

Summary and Objective

A&P Licensed Maintenance Controllers communicate directly with pilots regarding Aircraft Airworthiness and facilitate maintenance support when needed. The Maintenance Control Center (MCC) monitors all aspects of the maintenance process from AOG (Aircraft on Ground) to RTS (return to service).

Essential functions

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Communicates with Operations and advises of aircraft maintenance status changes.
• Coordinates maintenance operation issues on the Cessna Citation series aircraft.
• Ensure accurate and timely information is conveyed using Avianis/CAMP and Corridor systems.
• Evaluate reported aircraft discrepancies and develop an appropriate recovery plan.
• Ensures all aircraft that are down for maintenance are repaired safely, per OEM and Regulatory Instruction and in a timely manner.
• Evaluate reported aircraft discrepancies and develop an appropriate recovery plan.

Skills and Abilities:

• Must be able to work in a fast paced, occasionally stressful environment
• Ability to work weekends/holidays/possibly on call if needed
• Ability to read wiring diagrams and troubleshoot electrical circuits.
• Being a self-starter who is highly motivated with strong initiative
• Interpersonal skills with an emphasis on strong communication skills in both oral and written forms
• Effective time management
• Attention to detail
• Focus on excellence
• Adaptability
• Accountability and having hard conversations

Competencies

• Microsoft Office Suites
• More than proficient in Excel
• CAMP
• Corridor

Work environment

• Typical office and computer lab environment with frequent interruptions.
• Exposure to loud noises including airplane machinery and jet engines.

Physical demands

• Ability to see and hear clearly
• Ability to read, comprehend, and speak English clearly
• Ability to climb, twist, bend, crouch, stoop, kneel, and crawl
• Ability to move in tight quarters
• Ability to sit, stand, and walk for extended periods
• Ability to work in all weather conditions as needed
• Ability to regularly push/pull up to 70 pounds
• Ability to regularly lift/move up to 50 pounds

Required education and experience

• 3-5 years aviation maintenance experience required. (Military or Commercial, Corporate preferred)
• Prior Experience with Maintenance Task Management
• Applicants must hold an FAA (Federal Aviation Administration) Airframe and Powerplant License
• Must be authorized to work lawfully in the United States, must provide two forms of Federal Identification.
• Candidates must successfully complete a comprehensive background check prior to employment. This includes verification of previous employment, education, criminal history, and any other relevant information necessary to determine the suitability for the position.
• This position is classified as a Safety-Sensitive role under Federal Aviation Administration (FAA) regulations and is subject to pre-employment and random drug and alcohol testing in accordance with FAA guidelines

EEO statement

flyExclusive does not discriminate based on race, color, religion, sex (including pregnancy, sex stereotyping, gender identity, gender expression or transgender status), national origin, sexual orientation, physical or mental disability, age, protected genetic information, status as a parent, marital status, political affiliation, or retaliation based on prior protected EEO activity.

Other duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Do you thrive in an outdoor work environment and want to be part of an exciting environmental industry? Dragonfly Pond Works is a fast-growing company offering year-round work and long-term career opportunities. Join our \"swarm\" today!

Location: Raleigh, NC 27603

Pay: $22-$26 an hour- Full-time

• Leadership: 1+ year as a crew leader, supervisor, or foreman in a related industry.
• Experience: 2+ years in lake/pond maintenance, landscaping, commercial mowing, turf management, or erosion control.
• Ability to work on slopes, near water, and in various weather conditions.
• Results-driven with strong attention to detail.
• Team-oriented and aligned with Dragonfly's values: Quality Focus, Takes Ownership, and Growth Oriented.

• Lead field operations, including repairs to ponds, lakes, and stormwater control measures (excavation, grading, dredging, erosion control, planting, etc.).
• Track labor hours and materials to stay within budget.
• Interpret and apply engineering and grading plans on-site.
• Shoot grades to ensure accurate site construction.
• Safely operate equipment such as mini-excavators, skid steers, and hydraulic dredges.
• Communicate with Regional Managers and stakeholders to clarify scope and prevent rework.
• Complete and submit thorough Project Completion Reports.
• Monitor site activities of technicians and lead by example to encourage maximum productivity and safe work practices.
• Attend and participate in safety meetings such as safe driving of company-owned vehicles trucks (with or without trailers) and other OSHA topics.

• Health, Dental, and Vision Insurance
• 401(k) matching
• Life Insurance
• Flexible Spending Accounts
• Paid Time Off
• Holiday Pay
• Employee Assistance Program
• Referral Bonus
• Protective Footwear Bonus

Dragonfly Pond Works is a leading environmental service company specializing in stormwater management. Since 2006, Dragonfly has provided routine maintenance and repairs on stormwater devices, lakes, ponds, wetlands, and underground facilities.

We are proudly an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Average total pay: $14/hour+ ($10 hourly base pay + uncapped tiered commission structure, based on meeting your sales goal)

Comoto Holdings is America's largest and fastest-growing omnichannel platform in the powersports aftermarket-products industry; dedicated to advancing the experience of powersports enthusiasts across the globe. Comoto's brands, RevZilla, Cycle Gear, J&P Cycles, REVER, and Common Tread, deliver premium products, dedicated expertise, engaging media, and passionate customer support of the powersports community, through best-in-class e-commerce and retail experiences.

As a Sales Associate, you would be responsible for providing every customer with a great experience. You will be expected to maintain a strong sense of product knowledge, and to provide customers with in-depth information on product features and benefits.

You can expect our 5 Core Values to drive everything we do.

Aim For The Podium:

• We provide an outstanding shopping experience and deliver exceptional customer service. Sales Associates are responsible for hitting their daily/weekly/monthly sales goals
• Maintain store aesthetics by cleaning, stocking, organizing and following merchandising plans
• Stay up-to-date with our brand and product knowledge, company information, sales and company-wide events, truly becoming a resource to our customer base

Take Risks; Wear a Helmet:

• It never hurts to try something new. We are always looking to grow and progress and want to hear all your new ideas
• Don't be afraid to fail; no one is right all the time, but you can always be well-prepared

Share The Road:

• We take the health, safety, and wellness of our employees seriously. Our Wellness program and safety committee offers workshops, classes, resources, etc. to all of our team members
• Our Diversity, Equity, and Inclusion council and employee resource groups promote open and honest communication, remove barriers, and champion policies to build a more equitable environment
• Do the right thing, always. A friendly and upbeat personality is a must

Keep It Real:

• This is a part-time position. You'll earn an hourly base rate, plus you'll have a chance to earn commission on a tiered system, based on meeting your sales goal
• Additional incentives available, such as SPIFFS, plus we offer generous employee discounts on all products
• Because a whole lot of life happens between paychecks, Comoto also offers a voluntary benefit to all team members called DailyPay which allows for secure, instant transfers of earned pay before payday. This benefit is available to all team members immediately upon hire
• We strongly value training and development - with that, your first 5 shifts will be base pay only, so your only focus is learning

Fuel Your Passion:

• Work in an industry that you are passionate about!
• We are a growing company, and we promote from within - career opportunities!
• Exciting opportunities to represent Cycle Gear at special events -- International Motorcycle Show, motocross races, etc.
• We have the best customers! Riders are passionate, friendly, charitable, community-minded people, and we get to interact with them every day!

Our next Sales Associate has:

• 1 year + of sales or customer service experience
• A self-starter mentality that consistently delivers an outstanding, personalized retail experience
• An open mind, and is eager to learn and be a part of the riding community
• Experience with computers and POS systems (particularly RetailPro)
• Motorcycle riding, knowledge, or interest (desired, but not required)

Cycle Gear provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.

Benefits:

• 401(k) matching
• Flexible schedule
• Paid time off

Floor Coverings International is the number one in home flooring experience in North America. Raleigh Floor Coverings International boasts the largest revenue in the area and we have been voted Raleigh's Best in 2023 by the News and Observer. We are scaling up our business and we need expert salespersons to join our team. This is your opportunity to join a company with tremendous revenue potential. We have a great team culture and we strive to deliver outstanding customer service to all of our customers. This a base plus commission position. The right person will be able to work in a fast paced environment, connect with customers and have in home sales experience. The right individual will have a proven track record of sales revenue north of $1 Million per year. You must be excellent at prospecting, relationship building, networking and working with a longer sales cycle to close large projects.

Compensation: $75,000.00 - $175,000.00 per year

Floor Coverings International is the #1 mobile flooring franchise in North America. Our unique shop-at-home model allows customers to get perfect new floors without ever leaving their home. Our 400,000+ customers give us an average 4.8 star rating. That's a big reason why we're growing six times faster than our competitors. This rapid growth has increased our immediate need to keep up with demand by increasing the size of our teams. If you are a service-minded individual who loves to have fun we are the company for you!

This franchise is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of this franchisee. All inquiries about employment at this franchisee should be made directly to the franchise location, and not to Floor Coverings International Corporate.

At CarMax, we ensure customers can buy the vehicles they want in a way that suits them. That demands a special kind of sales consultant: one who takes time to build relationships with customers in order to understand their true needs. Join us, and you will help each customer purchase the right car, not the most expensive one. We've become the nation's largest retailer of used cars due to our honesty and transparency, and those same traits will help you succeed too.

What you will do Essential responsibilities

• Use your knowledge of CarMax inventory to assist customers in finding a vehicle that meets their needs
• Guide customers every step of the way, from sale or appraisal to test drives and arranging financing applications
• Complete all relevant records and documentation to ensure smooth transactions for our customers

CarMax pays new Sales Consultants a competitive wage while training and through the first 640 hours of selling, after which commissions become the primary base of pay.

Learn and succeed as part of a team

This is a high energy sales environment where you will work as a team to meet goals and we'll give you everything you need to be successful. Auto sales experience is not necessary we provide paid training and a personal sales mentor who is dedicated to your ongoing development. Bring us your ability to connect with people and build relationships, and we'll help you succeed. The prospects are bright for sales professionals who aspire to become mentors, managers and business leaders, and who are ready to work and learn as part of a team.

Qualifications and requirements

• Sales and customer service experience, in an area such as retail, is preferred
• Good listening skills and a strong customer focus
• High level of self-motivation
• Night & weekends are required

About CarMax

CarMax disrupted the auto industry by delivering the honest, transparent and high-integrity experience customers want and deserve. This innovative thinking around the way cars are bought and sold has helped us become the nation's largest retailer of used cars, with over 200 locations nationwide.

Our amazing team of more than 25,000 associates work together to deliver iconic customer experiences. Along the way, we help every associate grow their career and achieve their best, at work and in their community. We are recognized for our commitment to training and diversity and are one of the FORTUNE 100 Best Companies to Work For.

CarMax is an equal opportunity employer, and all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Upon an applicant's request, CarMax will consider reasonable accommodation to complete the CarMax Job Application.

From fewer hassles and better pay to flexible home time, were creating a more empowering and rewarding driving experience.

• Earn $70,000 or more annually
• Home time varies per location with this truck driving job*
• Sign-on bonuses may be available*
• Paid orientation - paid upon completion and hired
• 401(k) match + stock purchase plan
• Health, dental, & vision Insurance with prescription benefits for employees and dependents

At U.S. Xpress, were driven to safely provide creative and reliable freight solutions while cultivating a workplace where our people thrive. Whether youre a shipper, driver, or part of our support team, were committed to safety, integrity, empowerment, and tenacity in all we do.

• Unloading & stop pay on some dedicated accounts
• Short-term & long-term disability insurance
• Basic & supplemental life insurance
• Accidental Death & Dismemberment insurance
• Accident insurance
• Hospital Indemnity & Critical Illness coverage
• Health Care & Flexible Spending accounts
• Paid vacation may be available
• Employee assistance program
• 24/7 driver support
• Tuition reimbursement
• Pet insurance

• Must have Class A License (CDL A)
• Must be 21 years or older
• 3 months of verifiable experience
• No more than 2 CMV on-road preventable accidents
• No major CMV preventable accidents in the last 5 years
• No more than 2 moving violations
• No DUI/DWI within the past 5 years, or 10 years if the offense occurred while holding a CDL
• Must be able to pass a DOT physical and drug test. No drug-related conviction within the past 5 years, or 10 years if the offense occurred while holding a CDL. No positive/refused tests in the past 10 years with CDL-A/CLP
• SAP drivers are not eligible for hire