Overview In this role you lead GxP validation and qualification activities across manufacturing and analytical environments, ensuring GMP compliance and regulatory readiness. You serve as a site SME during inspections and drive successful NPI tech transfers and lifecycle programs. You'll manage change controls, oversee computer systems validation, and collaborate with R&D and global MSAT to accelerate product transfers. You enable robust data analysis and continuous improvement to meet quality standards and patient needs.
Compensation / Benefits- comprehensive benefits program
Responsibilities- GxP oversight of validation and qualification activities across processes, equipment, and facilities
- Approve phase-appropriate controls for production and laboratory value streams
- Lead New Product Introduction (NPI) tech transfers and ensure regulatory compliance
- Develop, review, and approve equipment validation protocols for facilities, utilities, equipment, laboratory equipment, and systems including CSV
- Determine change control requirements for validation and qualification activities
- Ensure validation activities comply with GSK standards and regulatory requirements
- Collaborate with enterprise partners (R&D, global MSAT/validation, Product Quality Leads) to accelerate product transfers
- Monitor validation data to identify trends and opportunities for improvement
- Participate in internal and external audits/inspections as validation and QA expert
- Oversee laboratory applications, methodologies, and automation to meet quality and CSV requirements
Key requirements- 10+ years in pharmaceutical/biotech industry with accountability for outcomes
- 5+ years of leadership experience
- Experience developing and executing process and equipment lifecycle management programs and related protocols/reports
- Bachelor's degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Pharmacy, Engineering)
- Strong leadership and team management
- Regulatory and quality mindset
- Cross-functional collaboration
- GxP validation and qualification
- Process validation
- Equipment validation
