Quality Control Director
GSK
9 days ago
Remote friendly (Marietta, PA)
United States
Operations
Position Summary
The Quality Control Director is responsible for leading Quality Control laboratory operations to ensure they are organizationally, technically, and operationally prepared to support commercial manufacturing and new product introductions across the validation lifecycle.
Responsibilities
- Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs.
- Ensure laboratories are inspection-ready and operate in compliance with regulatory and quality system requirements.
- Provide leadership for QC readiness for new product introductions, technology transfers, and lifecycle changes.
- Oversee method transfer and assay qualification activities.
- Ensure QC organizational readiness (staffing, training, onboarding, capability development).
- Support QC involvement in commissioning, qualification, and validation for laboratory facilities, equipment, and systems.
- Ensure laboratory data integrity and documentation accuracy (ALCOA).
- Partner with Manufacturing, QA, Engineering, Validation, and Development.
- Support internal/external audits and regulatory inspections.
- Contribute to continuous improvement and operational excellence.
Basic Qualifications
- Bachelor’s degree in a scientific/technical discipline (Chemistry, Biochemistry, Microbiology, or related).
- Minimum 8 years supervisory/managerial experience in a regulated GMP environment.
- Demonstrated QC laboratory operations experience.
- Experience supporting regulatory inspections and audits.
- Working knowledge of quality systems and regulatory expectations.
- Ability to lead teams and work cross-functionally.
Preferred Qualifications
- Master’s degree or PhD.
- Experience with new product introductions, method transfers, or technology implementations.
- Experience with digital laboratory systems, automation, or data/reporting tools.
Work Arrangement
On-site or hybrid (remote-only not available).
How to Apply
Submit your application and describe how your experience and leadership support the role.
The Quality Control Director is responsible for leading Quality Control laboratory operations to ensure they are organizationally, technically, and operationally prepared to support commercial manufacturing and new product introductions across the validation lifecycle.
Responsibilities
- Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs.
- Ensure laboratories are inspection-ready and operate in compliance with regulatory and quality system requirements.
- Provide leadership for QC readiness for new product introductions, technology transfers, and lifecycle changes.
- Oversee method transfer and assay qualification activities.
- Ensure QC organizational readiness (staffing, training, onboarding, capability development).
- Support QC involvement in commissioning, qualification, and validation for laboratory facilities, equipment, and systems.
- Ensure laboratory data integrity and documentation accuracy (ALCOA).
- Partner with Manufacturing, QA, Engineering, Validation, and Development.
- Support internal/external audits and regulatory inspections.
- Contribute to continuous improvement and operational excellence.
Basic Qualifications
- Bachelor’s degree in a scientific/technical discipline (Chemistry, Biochemistry, Microbiology, or related).
- Minimum 8 years supervisory/managerial experience in a regulated GMP environment.
- Demonstrated QC laboratory operations experience.
- Experience supporting regulatory inspections and audits.
- Working knowledge of quality systems and regulatory expectations.
- Ability to lead teams and work cross-functionally.
Preferred Qualifications
- Master’s degree or PhD.
- Experience with new product introductions, method transfers, or technology implementations.
- Experience with digital laboratory systems, automation, or data/reporting tools.
Work Arrangement
On-site or hybrid (remote-only not available).
How to Apply
Submit your application and describe how your experience and leadership support the role.