Quality Control Director
About The Position
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. 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. The position partners cross-functionally to ensure inspection readiness, regulatory compliance, and reliable delivery of high-quality laboratory data that supports site objectives and regulatory commitments.
Requirements
- Bachelor’s degree in a scientific or technical discipline (e.g., Chemistry, Biochemistry, Microbiology, or related field).
- Minimum of 10 years experience working 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.
- Demonstrated ability to lead teams and work cross-functionally to manage priorities and deliver results.
Nice To Haves
- Master’s degree or PhD in a scientific discipline.
- Prior people management or laboratory leadership experience.
- Experience supporting new product introductions, method transfers, or technology implementations.
- Experience with digital laboratory systems, automation, or data/reporting tools.
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.
Benefits
- Comprehensive benefits program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
