Quality Control Director
Listed on 2026-06-05
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Data Analyst
Position Summary
The Quality Control Director is responsible for leading quality control laboratory operations to support commercial manufacturing and new product introductions across the validation lifecycle.
This role provides scientific and operational leadership across analytical, biochemical, and microbiological laboratories supporting raw material testing, in-process and finished product testing, and stability programs. It partners cross‑functionally to ensure inspection readiness, regulatory compliance, and reliable delivery of high‑quality laboratory data that supports site objectives and regulatory commitments.
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 activities related to new product introductions, technology transfers, and lifecycle changes.
- Oversee method transfer and assay qualification activities in alignment with technical and regulatory requirements.
- Ensure effective QC organizational readiness, including staffing, training, onboarding, and capability development.
- Support QC involvement in commissioning, qualification, and validation activities for laboratory facilities, equipment, and systems.
- Ensure laboratory data integrity, documentation accuracy, and adherence to ALCOA principles.
- Partner with manufacturing, QA, engineering, validation, and development to support site priorities.
- Support internal and external audits and regulatory inspections.
- Contribute to continuous improvement initiatives and operational excellence within the QC organization.
- Bachelor’s degree in a scientific or technical discipline (e.g., chemistry, biochemistry, microbiology, or related field).
- Minimum of 8 years of supervisory/managerial experience within a regulated GMP environment.
- Demonstrated experience in quality control laboratory operations.
- Experience supporting regulatory inspections and audits.
- Working knowledge of quality systems and regulatory expectations.
- Demonstrated ability to lead teams and work cross‑functionally to manage priorities and deliver results.
- Master’s degree or PhD in a scientific discipline.
- Experience supporting new product introductions, method transfers, or technology implementations.
- Experience with digital laboratory systems, automation, or data/reporting tools.
This role is on‑site or hybrid, depending on site requirements. Remote‑only working is not available.
Equal Opportunity StatementGSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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