Quality Technical and Validation Manager
GSK
August 29, 2026
Remote friendly (Zebulon, NC)
United States
Operations
Position Summary:
Responsible for ensuring pharmaceutical facilities, equipment, systems, and processes are validated and maintained in a validated state; organizing/directing validation activities (including capital projects); providing technical support for process/product/facility and cleaning validation, change control, and continued verification for GMP/regulatory compliance and continuous improvement; and leading GMP-compliant delivery of laboratory business applications, analytical methodologies, instrumentation, automation, and data management.
Responsibilities:
- Drive Validation Life Cycle and Change Control; ensure DI requirements are incorporated/maintained.
- Develop/maintain the Validation Master Plan.
- Define/optimize product, process, facilities, and cleaning validation strategies/policies/programs (incl. QA-driven change control; benchmarking and continuous improvement).
- Oversee validation protocols for facility services/utilities/equipment/lab systems and computer systems in regulatory processes; lead analytical method transfer; manage equipment cleaning validation (incl. cleaning validation master plans) and laboratory equipment validation.
- Provide validation technical assistance; participate in cross-organizational validation efforts.
- Define project resourcing needs; assess/appoint/direct contractors/suppliers.
- Partner with business clients and influence Global/Regional service providers.
- Coordinate with EIS/IT to ensure uninterrupted software/hardware/network services; ensure lab application systems/instrumentation/automation support processes.
Why You?
Basic Qualifications (Required):
- BS (or equivalent) in Chemistry, Engineering, Quality, Pharmaceutical Operations, or related field.
- 10+ years pharmaceutical industry experience (15+ preferred).
- 7+ years validation in manufacturing/development (10+ preferred).
- Analytical equipment and analytical method validation experience.
- Validation project management (incl. capital projects).
- Experience leading validation/high-paced quality teams.
- Background in lab operations/lab applications/IT in a scientific environment.
- Strong expertise in analytical methodologies, lab/microbiology instrumentation, and pharma-related computer applications.
Preferred:
- cGMP knowledge (process validation/product characterization); analytical validation/transfer expertise.
- Resourcing knowledge; strong communication/presentation/reporting.
- Ability to supervise, collaborate across disciplines, influence others, and champion change/innovation.
Work model/location:
- Hybrid with regular on-site presence; remote flexibility as agreed with manager.
How to Apply:
- Apply with your resume and a short note on a recent validation challenge you led and the outcome.
Responsible for ensuring pharmaceutical facilities, equipment, systems, and processes are validated and maintained in a validated state; organizing/directing validation activities (including capital projects); providing technical support for process/product/facility and cleaning validation, change control, and continued verification for GMP/regulatory compliance and continuous improvement; and leading GMP-compliant delivery of laboratory business applications, analytical methodologies, instrumentation, automation, and data management.
Responsibilities:
- Drive Validation Life Cycle and Change Control; ensure DI requirements are incorporated/maintained.
- Develop/maintain the Validation Master Plan.
- Define/optimize product, process, facilities, and cleaning validation strategies/policies/programs (incl. QA-driven change control; benchmarking and continuous improvement).
- Oversee validation protocols for facility services/utilities/equipment/lab systems and computer systems in regulatory processes; lead analytical method transfer; manage equipment cleaning validation (incl. cleaning validation master plans) and laboratory equipment validation.
- Provide validation technical assistance; participate in cross-organizational validation efforts.
- Define project resourcing needs; assess/appoint/direct contractors/suppliers.
- Partner with business clients and influence Global/Regional service providers.
- Coordinate with EIS/IT to ensure uninterrupted software/hardware/network services; ensure lab application systems/instrumentation/automation support processes.
Why You?
Basic Qualifications (Required):
- BS (or equivalent) in Chemistry, Engineering, Quality, Pharmaceutical Operations, or related field.
- 10+ years pharmaceutical industry experience (15+ preferred).
- 7+ years validation in manufacturing/development (10+ preferred).
- Analytical equipment and analytical method validation experience.
- Validation project management (incl. capital projects).
- Experience leading validation/high-paced quality teams.
- Background in lab operations/lab applications/IT in a scientific environment.
- Strong expertise in analytical methodologies, lab/microbiology instrumentation, and pharma-related computer applications.
Preferred:
- cGMP knowledge (process validation/product characterization); analytical validation/transfer expertise.
- Resourcing knowledge; strong communication/presentation/reporting.
- Ability to supervise, collaborate across disciplines, influence others, and champion change/innovation.
Work model/location:
- Hybrid with regular on-site presence; remote flexibility as agreed with manager.
How to Apply:
- Apply with your resume and a short note on a recent validation challenge you led and the outcome.