Thermo Fisher Scientific · 1 week ago
Senior Manager, Quality
North Carolina, United States
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expThermo Fisher Scientific is a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development and commercial manufacturing. The Senior Manager, Quality will provide technical and compliance leadership for process and cleaning validation activities across the global manufacturing network, ensuring adherence to regulatory requirements and promoting a culture of quality and compliance.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
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
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
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
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
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
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
Must be legally authorized to work in the United States now or in the future, without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Preferred
Master's degree in Engineering, Life Sciences, or related field
Six Sigma, ASQ, or validation-related certification
Benefits
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Marc Casper
CEO
Stephen Williamson
Senior Vice President and Chief Financial Officer
Recent News
2026-01-21
Company data provided by crunchbase