Quality Technical and Validation Manager

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.

Basic Qualifications

• 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 Qualifications

• 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).