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.
Responsibilities
- Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs.
- Ensure laboratories are inspection-ready and comply 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 aligned with technical and regulatory requirements.
- Ensure QC organizational readiness: staffing, training, onboarding, and capability development.
- Support QC involvement in commissioning, qualification, and validation of 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/external audits and regulatory inspections.
- Contribute to continuous improvement and operational excellence within QC.
Qualifications
Required:
- Bachelorโs degree in a scientific/technical discipline (e.g., Chemistry, Biochemistry, Microbiology, or related).
- Minimum 8 years supervisory/managerial experience in 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.
- Ability to lead teams and work cross-functionally.
Preferred:
- Masterโs 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.