Pharmaceutical Sciences Ubc Jobs in Usa

Head of Quality & Regulatory Affairs

Company: DCL Products, LLC

Location: East Haven, CT 06512

Reports to: CEO / COO

Employment Type: Full-time, On-site

Position Summary

DCL Products, LLC — along with its wholly owned subsidiaries Milbar Labs, Inc. and Dermatologic Cosmetic Laboratories — is seeking an experienced Head of Quality & Regulatory Affairs to lead all aspects of quality, compliance, and regulatory oversight at our FDA-registered, cGMP-certified contract manufacturing facility specializing in beauty, skin care, and hair care products. This leader will ensure adherence to FDA regulations, current Good Manufacturing Practices (cGMP), customer quality standards, and industry best practices while fostering a strong culture of quality throughout the organization.

Key Responsibilities

Quality Management & Compliance

Develop, implement, and maintain the Quality Management System (QMS) in alignment with FDA and cGMP requirements.

Oversee all aspects of product quality, including raw material qualification, in-process controls, finished product release, and post-market surveillance.

Lead internal and external audits; ensure timely remediation of findings and continuous improvement of compliance programs.

Monitor changes in FDA regulations and other applicable global regulatory requirements; update company policies and procedures accordingly.

Regulatory Affairs

Act as the primary liaison with FDA and other regulatory authorities, ensuring all required documentation, registrations, and facility filings are complete and up to date.

Oversee product compliance, including label reviews, claims substantiation, and regulatory submissions as applicable.

Provide regulatory guidance to R&D;, manufacturing, and client services to ensure product development and commercialization meet compliance standards.

Testing & Validation

Oversee stability testing programs, including protocol development, sample management, data review, and reporting.

Ensure appropriate testing of raw materials, intermediates, and finished products in compliance with cGMP standards.

Approve product specifications, methods validation, and analytical testing procedures.

Leadership & Cross-Functional Collaboration

Lead, mentor, and develop the Quality and Regulatory Affairs team to foster a culture of excellence and accountability.

Collaborate with Operations, R&D;, Supply Chain, and Client Services to ensure quality standards are

integrated across all functions.

Provide training and guidance to employees at all levels on FDA regulations, cGMP, and quality expectations.

Qualifications

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field (advanced degree

preferred).

10+ years of experience in Quality Assurance, Quality Control, and Regulatory Affairs, preferably within cosmetics, personal care, or pharmaceutical manufacturing.

Strong working knowledge of FDA regulations, cGMP, ISO standards, and ICH stability guidelines.

Experience leading FDA inspections and customer audits.

Proven success in building and managing high-performing quality and regulatory teams.

Excellent communication, leadership, and problem-solving skills.

Compensation & Benefits

Competitive salary

Comprehensive health and welfare benefits package

401(k) retirement plan

3 weeks paid vacation

11 paid holidays

Why Join Us

This is a high-impact leadership role at an FDA-regulated contract manufacturer with a reputation for excellence in beauty, skin, and hair care products. You’ll have the opportunity to directly shape quality systems, regulatory compliance, and company growth while working in a collaborative, entrepreneurial environment.

RTD Biosciences is building a next-generation peptide manufacturing and analytical testing laboratory, and we are looking for a Lead Analytical Chemist / Lead Laboratory Technician to help build and operate the lab from the ground up.

This is a hands-on leadership role for a scientist who enjoys working with analytical instrumentation, solving complex technical problems, and helping establish laboratory systems in a growing pharmaceutical manufacturing environment.

You will play a key role in analytical testing, method development, manufacturing support, and regulatory compliance as we expand our operations.

What You'll Do:

Analytical Testing

• Operate HPLC, LC-MS/MS, and Q-TOF systems for peptide identity, purity, and potency testing
• Perform CoA testing including assay, related substances, endotoxin, sterility, and particulate analysis
• Develop and optimize analytical methods aligned with USP and FDA expectations

Manufacturing Support

• Support peptide production including formulation, sterile filtration, and lyophilization
• Execute batch records and perform in-process testing
• Troubleshoot formulation and stability issues

Quality & Compliance

• Author and maintain SOPs, analytical methods, and quality documentation
• Support FDA inspections and regulatory readiness
• Participate in deviation investigations and CAPA

Laboratory Leadership

• Coordinate sample testing workflows
• Train and mentor laboratory technicians
• Manage lab inventory, reagents, and equipment maintenance

Qualifications:

Required

• Bachelor’s degree in Chemistry, Biochemistry, or Pharmaceutical Sciences
• 5+ years of analytical laboratory experience
• Hands-on experience with HPLC systems
• Knowledge of cGMP and USP laboratory testing

Preferred

• Experience with LC-MS/MS or mass spectrometry
• Experience with peptides, biologics, or injectable drug products
• Background in 503B outsourcing facilities or sterile compounding
• Cleanroom or aseptic processing experience

Compensation:

$90,000 – $115,000 salary + performance bonus. Some room for negotiation based on experience.

Benefits include:

• Health, Dental, Vision
• 401(k)
• PTO
• Life Insurance
• Professional development support
• Advancement pathway to Laboratory Manager

To apply, please submit your resume and a brief cover letter describing your relevant

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with.

Every day, your talent, your innovative spirit, and your determination will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature.

Join us as our nextRegulatory Technical Manager reporting to our Head of global Regulatory and Product Safety. You will provide business-facing regulatory support and regulatory intelligence for cosmetic ingredients (Active Beauty) across North America and Latin America, ensuring compliant, timely and pragmatic responses to customer requests and proactive anticipation of regulatory changes.

The role acts as a key interface between customers, commercial teams and internal regulatory experts, supporting market access, customer confidence and sustainable growth of the Active Beauty portfolio, under the global governance of Fragrances Regulatory Global.

Salary expectation based on technical experience: $110,000.00 $130,000.00 usd.

Location: East Hanover, NJ.

In this exciting role you will:

Business & Customer Support

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  Be a first-line regulatory partner for commercial and customer-facing teams, addressing customer regulatory inquiries related to cosmetic ingredients.

  
  
  
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  Prepare customer-facing regulatory documentation (regulatory statements, compliance letters, ingredient status summaries, market-specific assessments).

  
  
  
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  Provide clear, and risk-based regulatory guidance to support customer projects and commercialization timelines.

  
  
  
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  Support resolution of customer regulatory issues and escalations, ensuring agreement between business needs and regulatory requirements.

  
  
  

Regulatory Surveillance & Impact Assessment

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  Perform regulatory monitoring for cosmetic ingredients in NOAM and LATAM (including the US, Canada, Brazil and main LATAM markets).

  
  
  
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  Analyze new regulations, guidance documents and enforcement trends improving cosmetic ingredients; assess potential business and portfolio impacts.

  
  
  
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  Translate regulatory developments into applicable insights for internal stakeholders (commercial, R&D, marketing, and product management).

  
  
  
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  Contribute to regional and global regulatory intelligence sharing within RAPS.

  
  
  

Portfolio & Compliance Support

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  Coordinate with global RAPS, toxicology and data management teams to ensure availability, consistency and accuracy of regulatory and safety data supporting Active Beauty ingredients.

  
  
  
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  Support compliance assessments and market readiness of cosmetic ingredient portfolios for NOAM/LATAM markets.

  
  
  
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  Contribute to internal understanding on regulatory positioning and customer messaging.

  
  
  

External Relations

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  Participate in relevant industry associations, working groups and regulatory forums related to cosmetic ingredients and specialty chemicals.

  
  
  
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  Support collection of external intelligence and contribute to advocacy efforts when relevant to Active Beauty portfolios.

  
  
  

Required Qualifications:

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  University / Bachelor's Degree in a scientific field (chemistry, biology, pharmaceutical sciences or equivalent).

  
  
  
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  6+ years of regulatory experience in cosmetics, cosmetic ingredients.

  
  
  
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  Fluent English

  
  
  
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  Understanding of cosmetic ingredient regulatory frameworks and customer expectations.

  
  
  
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  Ability to translate complex regulatory requirements into clear, business-oriented guidance.

  
  
  
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  Experience with regulatory systems, databases and regulatory intelligence tools.

  
  
  

Additional Qualifications:

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  Master's degree in Cosmetic Science

  
  
  
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  Experience in customer-facing regulatory support and regulatory surveillance.

  
  
  
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  Exposure to North America and Latin America regulatory environments (FDA, Health Canada, ANVISA, Mercosur)

  
  
  

What We Can Offer You:

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  Healthcare Plan:

  
  
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    Medical

    
    
    
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    Dental

    
    
    
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    Vision

    
    
    
  
  
  
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  High matching 401k plan (For the US)

  
  
  
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  Vacation days

  
  
  

#LI-Onsite

At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives.You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions.

Every essence of you enriches our world. Diversity drives innovation and creates closer connections with our employees, customers and partners. Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.

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• Support the setup and launch of the new Process Technologies & Development lab, including workspace organization, equipment installation support, and qualification readiness.
  
• Operate, maintain, and troubleshoot a broad range of primary container and analytical laboratory equipment, including:
  
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  • Leak detection systems
    
  • Headspace analyzers
    
  • Optical and particle counting microscopes
    
  • MicroCT scanners
    
  • Automatic filling equipment
    
  • Filtration and mixing tanks
    
  • Balances and related instrumentation
    
  
  
  
• Independently refine and develop laboratory processes and equipment workflows to improve efficiency, robustness, and usability.
  
• Maintain accurate equipment logs, calibration records, and instrument readiness documentation.
  
• Ensure laboratory organization, including consumables tracking, chemical inventory, and compliance with safety, quality, and documentation requirements.
  
• Partner with Facilities, Metrology, EH&S, and cross-functional Process Development teams to support seamless lab operations and timely issue resolution.
  

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• Apply sound scientific judgment in planning and troubleshooting experimental studies.
  
• Support method development, workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
  
• Drive continuous improvement in lab workflows, equipment utilization, and operational efficiency.
  
• Maintain a culture of cleanliness, organization, and scientific excellence within the laboratory.
  

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• Bachelor's or Master's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
  
• Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and laboratory best practices.
  
• Demonstrated experience designing and executing experiments with strong attention to detail and scientific rigor.
  
• Excellent organizational skills with a proven ability to maintain a clean, structured, and efficient laboratory environment.
  
• Strong communication skills and ability to manage multiple priorities in a fast-paced environment.
  

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• Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
  
• Familiarity with a broad range of laboratory equipment, including routine operation, troubleshooting, and maintenance.
  
• Experience with studies involving:
  
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  • Container Closure Integrity (CCI)
    
  • Extractables and Leachables
    
  • Device-drug interface evaluations
    
  • Fill-finish operations
    
  
  
  
• Ability to design and refine lab workflows that improve efficiency and usability across teams.
  
• Prior experience working within cross-functional development teams.
  

We are seeking a hands-on QC/QA Hybrid Manager to lead our quality control operations and compliance systems in a new peptide manufacturing lab. This role combines day-to-day QC supervision, batch review, and analytical oversight with strategic quality management, including SOP development, CAPA, and regulatory readiness.

The ideal candidate thrives in a startup environment, has experience with regulated laboratory operations, and is comfortable both mentoring staff and building robust quality systems from the ground up.

Key Responsibilities

Quality Control Operations

• Supervise QC testing workflows, including HPLC, LC-MS/MS, endotoxin, sterility, and CoA generation.
• Approve or reject batches for release in collaboration with production and analytical staff.
• Manage sample scheduling, instrument calibration, and lab documentation practices.
• Troubleshoot QC and analytical issues with the Lead Analytical Chemist.

Quality Management / Compliance

• Develop, implement, and maintain SOPs, batch records, change control, and CAPA processes.
• Ensure lab operations comply with cGMP, USP, FDA, and state Board of Pharmacy regulations.
• Lead regulatory and internal audits; prepare responses for inspections.
• Ensure data integrity, documentation accuracy, and environmental monitoring compliance.

Team Leadership

• Mentor and manage QC staff and lab technicians.
• Collaborate with Lead Analytical Chemist, Production Lead, and Lab Director to coordinate lab operations.
• Foster a culture of compliance, accountability, and continuous improvement.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 5–10+ years in regulated lab environments with hands-on QC and quality oversight.
• Proven experience with HPLC, LC-MS/MS, sterility, and endotoxin testing.
• Strong knowledge of cGMP, USP, FDA regulations, and quality systems.
• Experience writing and reviewing SOPs, batch records, and CAPAs.
• Demonstrated leadership and team management experience.
• Excellent documentation, analytical, and problem-solving skills.

Preferred Qualifications

• Experience in 503B outsourcing facilities, sterile compounding, or injectable manufacturing.
• Prior exposure to FDA, State BOP, or third-party audits.
• Knowledge of peptide chemistry, lyophilization, and stability testing.
• Ability to work in a fast-growing startup lab environment.

Compensation & Benefits

• Salary: $115,000 – $145,000, depending on experience.
• Total Comp: Up to $160,000 with performance-based bonus.
• Health, Dental, Vision, 401K, Life Insurance, PTO.
• Opportunity to grow into Lab Director or QA leadership roles as the lab expands.
• Professional development support (conferences, certifications).

Our client is seeking a strategic and experienced leader to oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) from lead optimization through commercialization. This role will drive formulation, process development, clinical supply chain, and regulatory strategy—especially focused on Phase 3 and long-term extension studies.

Key Responsibilities:

• Lead internal teams and external CDMO partners across CMC functions
• Oversee manufacturing, analytical development, tech transfer, and clinical supply logistics
• Ensure regulatory readiness and author CMC sections for global filings (INDs, NDAs, IMPDs)
• Collaborate cross-functionally with Regulatory, Quality, and Clinical teams
• Manage department budgets and ensure operational excellence across the portfolio

Qualifications:

• PhD in pharmaceutical sciences, chemistry, or related field
• 15+ years of industry experience, including 10+ years in senior CMC leadership
• Deep expertise in injectable drug products and synthetic peptide manufacturing
• Strong understanding of global regulatory guidelines (ICH, FDA, EMA, USP)
• Proven success managing CDMO relationships and leading cross-functional teams

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Consultant, Commercial Analytics Manager

Summary

Our mid-sized, growing pharmaceutical client is seeking a Data Analyst professional who is highly motivated and a strategic individual responsible for supporting the commercial success of our clients pharmaceutical brands. This role combines advanced analytics, data visualization, and storytelling to generate actionable insights that influence brand strategy and leadership decision-making. The ideal candidate will bring strong analytical capabilities, expertise in pharmaceutical data, and a collaborative mindset to drive performance across the organization.

Responsibilities

• Translate complex analytics into clear, actionable insights.
• Develop compelling, data-driven narratives to support brand strategy and executive decisions.

Power BI Development

• Design, build, and maintain interactive, user-friendly dashboards to track brand and portfolio performance.
• Continuously enhance visualizations based on evolving business needs.

Ad-Hoc Analytics & Creative Problem Solving

• Conduct deep-dive analyses to support new brand launches and optimize in-line brands.
• Apply creative thinking to uncover insights and solve complex business questions.

Portfolio Performance Management

• Monitor and analyze KPIs across a portfolio of assets.
• Identify trends, risks, and opportunities to inform strategic decisions.

Vendor Management

• Coordinate with external analytics vendors to ensure timely, high-quality deliverables.

Cross-Functional Collaboration

• Partner closely with Marketing, Sales, Market Access, Forecasting, Finance, and Market Research teams to inform brand strategy and tactical execution.

Data Integrity & Industry Awareness

• Ensure data accuracy, consistency, and integrity across all reports and tools.
• Stay abreast of industry trends, competitive intelligence, and evolving analytical methodologies.

Qualifications/Experience:

• 3+ years of experience in pharmaceutical data science, brand analytics, or commercial analytics, with at least 2 years in the pharmaceutical or life sciences industry.
• Experience with specialty pharmacy data and related analytics.
• Strong command of pharma data sources (e.g., IQVIA, Symphony, Komodo, claims data, specialty pharmacy, field activity data).
• Proficiency in data visualization & analytics tools (Power BI, Tableau, Excel, SQL, Python, or SAS).
• Preferred: Experience in nephrology, rare disease, oncology, or specialty pharmacy distribution.
• Education: Bachelor’s degree in Business, Statistics, Economics, Life Sciences, Computer Science, or a related field.

Term & Start

• 12 month contract – possible option to extend.
• Start 2-3 weeks from an offer.
• Remote with ability to go onsite 1 X per week in Princeton, NJ
• Benefits available (Medical, Dental, Vision, 401k

IQVIA is a leading global provider of research and development, commercial solutions, and technology-enabled services to the life sciences industry. We help customers accelerate innovation and improve patient outcomes by combining deep scientific expertise with advanced data assets, transformative technology, and integrated services. IQVIA Digital builds on this foundation to deliver omnichannel engagement strategies powered by privacy-optimized data, advanced analytics, and scalable technology, enabling pharmaceutical companies to connect with healthcare professionals and patients in meaningful, measurable ways.

The Pharma Segment Lead defines and drives IQVIA Digital's segment-level strategy for pharmaceutical clients. This role sets the vision for how we position our capabilities and value proposition, ensuring alignment with client needs and market trends. The Pharma Segment Lead combines strategic thinking with hands-on storytelling, creating compelling narratives and resources that enable sales, marketing, and product teams to win and grow business. The role is accountable for measurable commercial outcomes and plays a critical part in IQVIA Digital's continued growth trajectory.

Segment Strategy:

• Develop and own the segment strategy for IQVIA Digital offerings across large pharma and other prioritized segments, including key accounts and EBP (pre-commercial, small, and mid-sized pharma).
• Identify growth opportunities, prioritize products and solutions, and influence product development roadmaps to address gaps.
• Participate in strategic forums such as product summits to pressure-test ideas and ensure alignment with market needs.
• Monitor market trends, competitive dynamics, and customer needs to inform strategy and scenario planning.

Strategic Storytelling:

• Craft and adapt executive-ready narratives that articulate IQVIA Digital's vision, capabilities, and proof points, tailored by segment and therapeutic area (oncology, rare disease, immunology, cardiometabolic).
• Build clear, concise, and compelling presentations for client innovation days and senior-level engagements.

Collaboration & Client Engagement:

• Lead planning for client innovation days and strategic meetings, partnering with Sales and Product to define objectives, storyboards, and partnership opportunities.
• Serve as a commercial strategy SME in high-level pharma client meetings and innovation days.
• Support Sales in key strategic meetings by co-leading preparation and delivery of material.
• Collaborate with Marketing and Thought Leadership teams to shape and amplify IQVIA Digital's points of view, ensuring consistency across external engagements.

Commercial Enablement:

• Package offerings for lead generation and sales enablement, ensuring resources are current and aligned with GTM priorities.
• Contribute to strategic account reviews and cross-functional initiatives to integrate IQVIA Digital solutions into broader offerings.

Partner Strategy & Innovation:

• Contribute to GTM partner strategy including leading evaluation, recommendation, and implementation of partners.
• Identify emerging technologies or partnerships that could enhance IQVIA Digital's value proposition.

Customer Experience & Data-Driven Insights:

• Champion a customer-centric approach to solution design and engagement.
• Leverage data and analytics to inform strategy and track performance.

- 10+ years in pharmaceutical brand and/or marketing roles; agency experience strongly preferred.

- Management consulting experience in life sciences or healthcare strategy is highly desirable.

- Recognized industry presence through publications, speaking engagements, or thought leadership contributions.

- Proven ability to develop and deliver strategic narratives and executive-ready presentations.

- Deep understanding of pharma customer needs across functions and market trends shaping future requirements.

- Experience across major therapeutic areas (oncology, rare disease, immunology, cardiometabolic).

- Exceptional skills in strategic thinking, storytelling, slide design, and cross-functional collaboration.

Approximately 5% (one trip per quarter for client meetings or industry events).

To be eligible for this position, you must reside in the same country where the job is located.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role, when annualized, is $121,400.00 - $338,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Role at a Glance

Employment Type: Full-time | Department: Quality | Reports to: Director of Quality

Experience Level: 1–3 years hands-on QC experience in a manufacturing environment ( preferably nutraceutical, food, animal health or pharmaceutical).

Work Location: Onsite – Noblesville, IN; Travel: 0-10%.

About Verdure Sciences

For nearly three decades, Verdure Sciences has been pioneering botanical ingredient excellence. From our sustainable sourcing partnerships to our branded ingredients like Longvida® Curcumin and Pomella® Pomegranate, our partners—global consumer brands—trust our commitment to botanical integrity and quality.

You will be a key member of our Quality team ensuring that every batch meets specifications, regulatory requirements, and customer standards. The focus is practical, day-to-day QC execution: coordinating testing with contract labs, reviewing data for release, and maintaining right-first-time documentation under cGMP.

We are specifically prioritizing candidates with hands-on QC experience in manufacturing environments.

Key Responsibilities

• Prepare samples and coordinate testing with qualified third‑party labs aligned to customer specifications and QC test plans.

• Review physical, chemical, and microbiological data; resolve discrepancies and confirm compliance to specifications for batch release.

• Generate Certificates of Analysis (CoA), verify labels, and execute batch release documentation with right‑first‑time accuracy and communicate with suppliers.

• Manage traceability, retains, and stability program records (sampling plans, storage, pulls, and data trending).

• Support in‑house testing routines as needed.

• Maintain document control: specifications, test methods, SOPs, and change control records.

• Participate in quality events: nonconformances, investigations, CAPA/VCAR creation, and effectiveness checks.

• Partner cross‑functionally (Supply Chain, R&D, Sales/Account teams) to resolve issues and meet customer quality expectations.

• Assist with internal/external audits (e.g., NSF, USP, Organic, Non‑GMO) and vendor/contract lab qualifications.

• Stay up to date with industry regulations and best practices related to botanical ingredients and dietary supplements.

What You’ll Bring (Required)

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Food Science or similar).

• 1-3 years of paid, hands‑on QC experience in dietary supplement, food, animal health or pharmaceutical manufacturing.

• Working knowledge of cGMP (e.g., FDA 21 CFR 111) and quality systems (deviations, CAPA, change control, data integrity).

• Experience reviewing third‑party lab reports and in‑house data; confident interpreting common analytical and microbiological methods.

• Proficiency creating CoAs and maintaining controlled documents; strong attention to detail and organization.

• Fluency with Microsoft Office and Adobe.

• Clear, professional communication skills and a collaborative approach with vendors and internal teams.

Preferred experience:

• Direct experience with dietary supplement/botanical regulations and audits (NSF, USP, Organic, Non‑GMO).

• Qualifying and managing third‑party labs; vendor performance monitoring.

• Statistics/data trending for QC (e.g., control charts, out‑of‑trend checks).

• Electronic quality/document systems and CRM systems (TrackWise, Veeva, SharePoint, Hubspot).

Work Environment & Schedule

Onsite at our Noblesville, IN office/lab | Monday–Friday, 8:30 a.m.–5:30 p.m.

Our Hiring Approach

Verdure Sciences is an Equal Opportunity Employer. We consider all qualified applicants without regard to protected characteristics and provide reasonable accommodation as required by law.

If you bring experience from botanical extracts, herbal ingredients, or plant-based nutraceuticals and have a discovery mindset for innovative quality solutions, we'd love to connect. This is your opportunity to make a meaningful impact in an industry where quality genuinely matters.

Work authorization: Applicants must be currently authorized to work in the United States on a full‑time basis.

#BotanicalIngredients #Quality #PlantBased #vsCares #Indiana #Hiring #vsLongvida #vsPomella

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.