The primary purpose of the Quality Control (QC) Manager, Stability position is to manage all aspects of the stability program, including sample management and stability oversight, and ensure compliance with internal procedures, industry regulations and regulatory guidance documents.
- Write, execute and manage the stability program in support of all three manufacturing phases, including oral solid dose, prefilled syringes/vials and nebulizer products.
- Ensure that the program is in alignment with FDA, ICH, WHO and other international agencies.
- Manage and facilitate completion of all stability-related tasks, including sample request, receipt, labelling, lay down procedure, calculation and execution of stability pulls.
- Prepare, review and/or approve deviations, out-of-specification reports, formal investigations, non-conforming material results and compliant investigations.
- Organize and execute shipment to off-site storage and/or laboratory facilities.
- Coordinate with QC management for scheduling of stability sample analysis.
- Ensure data is managed and evaluated, including the creation, review and trending, to meet company, industry and regulatory requirements.
- Manage stability chambers, including daily monitoring and excursion evaluation.
- Write and maintain SOPs in support of the stability program.
- Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the Stability and Quality Control departments.
- Represent Company as appropriate in FDA, notified body, internal and other regulatory audits.
- Evaluate and continuously improve stability systems, quality and compliance with regulatory requirements, best practices and quality systems procedures.
- Be proactive with regulatory and industry changes.
- A minimum of a Bachelor’s degree in Science is required.
- A minimum of 7 years or more of experience in a Pharmaceutical Quality Control Laboratory environment, including experience with conducting stability studies.
- A minimum of 2 years or more of laboratory managerial experience, including involvement with regulatory audits.
- Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), cUSP and ICH Q1A (R2).
- Experience with statistical applications for stability data evaluation and shelf-life determination.
- Strong documentation skills are required, including writing SOPs, technical papers and investigations.
- Proficiency with Microsoft Word, Microsoft Excel and Microsoft Power Point are required.
- Strong organizational and communicative skills are imperative.
- The ability to work independently and within a team structure and on multiple projects, with flexibility to adapt to changing priorities is required.
Must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills.