Senior Manager, Quality

Thermo Fisher Scientific-posted 1 day ago
Full-time • Mid Level
Onsite • Durham, NC
5,001-10,000 employees
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Pharma Services Group (PSG) at Thermo Fisher Scientific is a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing. Biotech and biopharma companies trust us for our speed, flexibility, and quality across every phase of drug development. With worldwide locations, we support active pharmaceutical ingredients (APIs), biologics, cell therapy, viral vectors, formulation, clinical trials, logistics, commercial manufacturing, and packaging. As part of our Global Quality organization within PSG, you will play a crucial role in ensuring the highest standards of quality and compliance across our global manufacturing network. DESCRIPTION: The Senior Manager, Process and Cleaning Validation is responsible for providing technical and compliance leadership for the design, execution, and governance of process and cleaning validation activities across the company's global manufacturing network. This role ensures that all validation activities—including process performance qualification (PPQ), cleaning validation, and lifecycle monitoring—are scientifically sound, risk-based, and compliant with global regulatory requirements (FDA, EMA, WHO, PIC/S, and ICH Q7–Q10). The incumbent will serve as a global subject matter expert (SME) providing strategic oversight, technical guidance, and harmonization of validation programs across sites and functions within the Pharma Services Group.

  • Global Validation Governance Lead and maintain the corporate Process and Cleaning Validation Program in alignment with global policies, regulatory expectations, and PSG's commitment to quality and compliance.
  • Ensure that all validation strategies are science- and risk-based, in accordance with FDA Process Validation Guidance, Annex 15, and ICH principles, supporting PSG's end-to-end services for drug development.
  • Support the development, implementation, and continuous improvement of the Global Validation Master Plan (VMP) across PSG's worldwide locations.
  • Provide quality and technical oversight for validation lifecycle management, including initial validation, revalidation, and ongoing verification, ensuring consistency across PSG's diverse product portfolio.
  • Process & Cleaning Validation Leadership Develop and review process validation protocols and reports, ensuring compliance and sound scientific rationale for APIs, biologics, cell therapies, and viral vectors.
  • Define and implement cleaning validation strategies based on toxicological risk assessments and product changeover considerations, crucial for PSG's multi-product facilities.
  • Partner with Manufacturing Science & Technology (MS&T), Operations, and Quality Control to ensure validated state is maintained throughout the product lifecycle, from early-phase development to commercial manufacturing.
  • Support process robustness programs, continued process verification (CPV), and validation trend analysis across PSG's global manufacturing network.
  • Regulatory Compliance and Inspection Support Act as the subject matter expert (SME) during regulatory inspections, internal audits, and external agency interactions related to validation, supporting PSG's reputation for quality and compliance.
  • Ensure timely closure of validation-related observations and CAPAs across all PSG sites.
  • Monitor emerging regulatory requirements and proactively update global validation standards to maintain compliance, supporting PSG's ability to meet diverse client needs.
  • Standardization and Continuous Improvement Lead harmonization of validation policies, templates, and practices across PSG sites to ensure global consistency and efficiency.
  • Drive implementation of digital validation systems (e.g., eQMS or validation lifecycle management tools) for documentation control and data integrity, enhancing PSG's operational excellence.
  • Identify and implement continuous improvement opportunities to increase validation efficiency and compliance robustness, supporting PSG's commitment to speed and flexibility.
  • Training and Capability Building Develop and deliver validation training programs for global and site teams within PSG.
  • Mentor validation engineers and quality staff in lifecycle validation principles and regulatory compliance, fostering a culture of quality within PSG.
  • Support technical onboarding and competency development across the global validation network, ensuring PSG maintains its high standards of expertise.
  • Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
  • 8–10 years of experience in validation, quality, or technical roles within the pharmaceutical or biopharmaceutical industry, preferably in a CDMO environment.
  • Deep understanding of process and cleaning validation principles and lifecycle approaches (Stage 1–3 per FDA guidance) across various modalities including APIs, biologics, cell therapies, and viral vectors.
  • Proven knowledge of global regulatory frameworks: FDA, EMA, WHO, ICH Q7–Q10, and Annex 15, with experience in applying these to diverse product types and manufacturing processes.
  • Experience supporting or leading regulatory inspections (FDA, EMA, MHRA, WHO, etc.) in a multi-product, global manufacturing environment.
  • Strong leadership, collaboration, and problem-solving skills within global, matrixed organizations, essential for success in PSG's diverse and dynamic environment.
  • Proficiency with validation documentation systems and electronic quality management systems (eQMS), with experience in implementing or improving such systems across multiple sites.
  • Six Sigma, ASQ, or validation-related certification preferred.
  • Medical, Dental, & Vision benefits-effective Day 1
  • Paid Time Off & Designated Paid Holidays
  • Retirement Savings Plan
  • Tuition Reimbursement
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