The QC Manager will provide support for all aspects of commercial operations for APIs, Drug Products ensuring compliance with regulatory guidelines and GMP/quality standards.
Through collaboration with business partners, the QC Manager will ensure that QC support is provided to meet commercial objectives, supply chain requirements and ensure successful outcomes from interactions with Health Authorities, including inspections, regulatory filings and meetings. The Manager of Quality Control will ensure that appropriate oversight and direction is provided for QC testing at contract testing laboratories and contract manufacturing operations. Additional responsibilities will include cross-functional team membership. Responsible for developing and maintaining functions of Quality Control and ensure that all activities are fully in compliance with cGMP standards.
The QC Manager will report to the Director, Quality Control
- Management of stability programs for all products
- Lead out-of-specification (OOS)/out of trends (OOT) analytical deviations
- Provide analytical/technical support to Technical Operations and CMOs
- Ensure that operations within CMOs and contract testing laboratories are compliant with cGMPs
- Manage analytical method transfers/validation programs in compliance with regulatory/ requirements
- Troubleshooting of analytical methods
- Operate CAPA/deviation, training and compliance systems
- Develop and author SOPs, analytical validation protocols and reports.
- Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
- Report Quality Control Metrics
- Product trending programs for all products at release and stability
- Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).
- Support the creation and maintenance of regional and global quality control and laboratory systems in relation to quality control operation. Actively support QC system improvements to ensure the efficient, effective and compliant process
- Management of reference standard programs for all products
- Ensure of compendial method updates implemented as appropriate for products
Ensure that budgets, cost and reporting on financials associated with commercial QC activities
Identify and implement Continuous Improvement programs as appropriate within
- Work closely with other members of the Technical Operations group and CMOs to ensure delivery of key project objectives
- Assist with troubleshooting quality control issues at CMOs when required.
- Maintain appropriate Quality Technical Agreements with all GxP vendors
- Supporting regulatory submissions as required
- This position may require up 15 % travel
- Bachelors of Science, Masters or Ph.D. degree in biochemistry, chemistry or a related discipline
- At least 8-10 years’ experience working in a laboratory/quality environment within the pharmaceutical industry
- Experience in finished product pharmaceuticals/biologics/APIs desirable
- Demonstrated knowledge of quality systems, FDA and EU guidelines as the relate to analytical testing/product manufacturing
- Experience with regulatory inspections and submission of regulatory filings
- Strong Interpersonal skills and professional skills to interact at all levels including senior management, contractors, and colleagues
- Excellent communication and time management skills
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