Quality Technical and Validation Manager
GSK
August 21, 2026
Remote friendly (Zebulon, NC)
United States
Operations
Position Summary:
- Ensure facilities, equipment, systems, and processes for pharmaceutical manufacture/testing are validated and maintained in a validated state.
- Organize and direct validation activities, including capital projects.
- Support process/product/facilities/cleaning validation, change control, and continued verification for GMP and regulatory compliance and continuous improvement.
- Lead compliant validation and change control efforts.
- Provide leadership to deliver laboratory business applications, analytical methods, instrumentation, automation, and data management in a GMP-compliant manner.
Responsibilities:
- Drive Validation Life Cycle and Change Control; ensure DI requirements are incorporated/maintained.
- Develop/maintain the Validation Master Plan.
- Define/optimize validation strategies, policies, and programs (incl. cleaning validation and change control).
- Manage/oversight validation protocols for facility services/utilities/equipment, lab systems, and computer systems in regulatory processes; oversee analytical method transfers and equipment cleaning validation; oversee laboratory equipment validation.
- Provide validation technical assistance across organizations; participate in cross-org validation efforts.
- Determine engineering/validation resourcing needs; assess/appoint/direct contractors/suppliers.
- Partner with business clients and influence IT/EIS and global/regional service providers to meet application and service requirements.
Why You?
Basic Qualifications (required):
- BS or equivalent in Chemistry/Engineering/Quality/Pharmaceutical Operations (or related).
- 10+ years pharma industry (15 preferred); 7+ years validation in manufacturing/development (10 preferred).
- Analytical equipment and analytical method validation experience.
- Manage validation projects (including capital projects); lead validation teams/high-pace quality/ops teams.
- Laboratory operations/applications or scientific IT background; strong technical expertise (analytical methodologies, instrumentation, computer apps).
Preferred:
- cGMP knowledge (process validation/product characterization), analytical validation/transfer expertise; resourcing concepts.
- Strong communication, troubleshooting, collaboration, supervision; GPS training.
Work model:
- Hybrid; regular on-site presence with remote flexibility as agreed.
How to Apply:
- Apply with resume and a short note on a recent validation challenge you led and the outcome.
- Ensure facilities, equipment, systems, and processes for pharmaceutical manufacture/testing are validated and maintained in a validated state.
- Organize and direct validation activities, including capital projects.
- Support process/product/facilities/cleaning validation, change control, and continued verification for GMP and regulatory compliance and continuous improvement.
- Lead compliant validation and change control efforts.
- Provide leadership to deliver laboratory business applications, analytical methods, instrumentation, automation, and data management in a GMP-compliant manner.
Responsibilities:
- Drive Validation Life Cycle and Change Control; ensure DI requirements are incorporated/maintained.
- Develop/maintain the Validation Master Plan.
- Define/optimize validation strategies, policies, and programs (incl. cleaning validation and change control).
- Manage/oversight validation protocols for facility services/utilities/equipment, lab systems, and computer systems in regulatory processes; oversee analytical method transfers and equipment cleaning validation; oversee laboratory equipment validation.
- Provide validation technical assistance across organizations; participate in cross-org validation efforts.
- Determine engineering/validation resourcing needs; assess/appoint/direct contractors/suppliers.
- Partner with business clients and influence IT/EIS and global/regional service providers to meet application and service requirements.
Why You?
Basic Qualifications (required):
- BS or equivalent in Chemistry/Engineering/Quality/Pharmaceutical Operations (or related).
- 10+ years pharma industry (15 preferred); 7+ years validation in manufacturing/development (10 preferred).
- Analytical equipment and analytical method validation experience.
- Manage validation projects (including capital projects); lead validation teams/high-pace quality/ops teams.
- Laboratory operations/applications or scientific IT background; strong technical expertise (analytical methodologies, instrumentation, computer apps).
Preferred:
- cGMP knowledge (process validation/product characterization), analytical validation/transfer expertise; resourcing concepts.
- Strong communication, troubleshooting, collaboration, supervision; GPS training.
Work model:
- Hybrid; regular on-site presence with remote flexibility as agreed.
How to Apply:
- Apply with resume and a short note on a recent validation challenge you led and the outcome.