Director of Quality Control
- Director of Quality Control
A well established CMO focused on topical treatments is seeking a Director of Quality Control to join team! This privately held company that has been in the industry for over 120 years, and the current owners still maintain a family line to the original founders of the company. Now is a pivotal time to get in with this group as the Director of QC as you will be responsible for the future of the entire QC/Analytical Method Development department, and have a major impact on the organization as a whole.
The Director of Quality Control will have the following responsibilities:
- Provides annual goals and objectives for Quality Control and AMD by developing, implementing and managing annual operating budget, approving expenditures, monitoring staff, ensuring compliance with regulations and policies, as well as managing training in various areas.
- Ensures the proper laboratory documents are implemented and assures utilization of SOPs, Specifications, Forms, Test Methods, Protocols, and Reports.
- Ensures laboratory cGMP and GLP compliance and adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, chemistry, methods validation and stability.
- Ensures the laboratory operates in a safe and hazard free manner.
- Ensures current knowledge and implementation of FDA/ICH guidance documents and USP/EP requirements.
- Review FDA response requests originating from the laboratories e.g. 483 observations.
- Review and responds to third party customer audits.
- Review and approve raw material, finished product and stability test data generated in the Quality Control Laboratory as required.
- Ensure the timely reporting of accurate data to all executive management, providing accurate and timely updates on QC and AMD activities with a focus on cycle times, staff productivity and cost management.
- Identify and resolve obstacles to maintain a highly productive and functional group.
- Provide project management support to guarantee timely completion of the different department responsibilities.
- Responsible for the timely hiring, training and development of qualified staff to ensure effective testing, execution of roles and responsibilities, GMP and GLP compliance, and attainment of operational and development goals.
- Interact with customers, contract laboratories, auditors and regulatory agencies. Support agency and other third party inspections.
- Responsible for short and long team goals of QC laboratory efforts and Business Development interests in contract manufacturing in support of IND, CMC, NDA, ANDA clinical efforts and commercial product supply.
- Oversees and approves laboratory investigations and non-conforming material investigations.
- Coordinate projects across the different responsibility areas to meet production schedules and project time lines.
- Interface with Development, Regulatory, Quality groups, and manufacturing and Technical service groups and cross functional teams. Attend meetings where laboratory and technical input is needed and encourage intradepartmental communication.
- Collaborate with Quality Assurance, Validation, Product Development, and Manufacturing Personnel to resolve production problems.
- Recommend laboratory capital improvements.
The ideal candidate will have the following skill set:
- Graduate degree in scientific discipline required; preferred Analytical Chemistry.
- Must have 5+ years managerial/supervisory experience in the pharmaceutical industry in a Quality Control related position. Liquid and semisolid experience a plus.
- Excellent communication skills.