Quality Control Director

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.

Qualifications

• 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.