GSK · 3 days ago
Quality Technical and Validation Manager
Marietta, PA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expGSK is a global biopharma company dedicated to manufacturing and supplying high-quality medicines and vaccines. The Quality Technical and Validation Manager will oversee GxP compliance in validation and qualification processes, ensuring adherence to regulatory standards while leading a team focused on quality oversight for new product introductions and validation activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
GxP Oversight of Validation and Qualification Activities
Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities
Determine phase specific controls, and ensure their adherence, for the production and laboratory value streams
New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with GSK and regulatory standards. This includes review and approval of process and analytical tech transfer tasks and protocols
Develop, Review and approve equipment validation protocols for all facility services, utilities, equipment, laboratory equipment and systems including computer systems
Determines change control requirements, including for validation and qualification activities
Ensure that all validation activities are current and conducted in accordance with GSK's quality standards, regulatory requirements, and industry best practices
Work with enterprise partners (R&D, global MSAT/validation, Product Quality Leads) in identifying, evaluating and initiating strategies to rapidly developing product transfers by developing a partnership with the business areas to which they are aligned
Monitor and analyze validation data, identifying trends and areas for improvement
Participate in internal and external audits and inspections, providing expertise on validation and quality assurance matters
Oversee laboratory business applications, methodologies, and automation to ensure they meet quality and compliance standards including their respective Computer System Validation (CSV) requirements
Qualification
Required
Bachelor's degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Pharmacy, Engineering)
10+ years of experience in the pharmaceutical or biotechnology industry, responsible/accountable for decisions and their outcomes
5+ years of leadership experience
Experience in developing, approving, and executing process and equipment lifecycle management programs (Continued Process Verification, Validation Master Plans, etc.), and their underpinning protocols and reports
Preferred
Advanced degree (e.g., Master's, Ph.D.) in a relevant scientific or engineering discipline
Strong skills to identify business requirements and to provide solutions to complex issues
Strong knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards for validation and quality assurance
Certification in quality assurance or validation (e.g., ASQ, ISPE)
Experience with continuous improvement methodologies (e.g., Six Sigma, Lean)
Benefits
Comprehensive benefits program GSK offers US employees
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase