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Head of Quality Assurance and Regulatory Affairs
Il y a 2 mois
Cpl Life Sciences is a leading global pharmaceutical company specializing in the development, manufacture, and commercialization of high-quality veterinary pharmaceuticals and related products. Our company provides cutting-edge solutions to veterinarians, pet owners, and livestock producers worldwide.
We are dedicated to advancing animal health and welfare, with significant investments in research and development to bring novel treatments to market. Through strategic partnerships and acquisitions, we continue to expand our presence in key markets, contributing to impressive year-on-year growth.
About the RoleWe are seeking an experienced leader to take on the role of Director of Quality CMC Development. This pivotal position involves working collaboratively to bridge the Product Development & Regulatory Affairs (PDRA) teams with manufacturing, encompassing a large workforce.
The role is crucial in establishing the function and ensuring seamless integration between quality, product development, and manufacturing teams.
Responsibilities- Develop and Implement Quality Management Systems: Ensure phase-appropriate cGMP compliance and develop quality management systems that meet regulatory requirements.
- Collaborate with Cross-Functional Teams: Work closely with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and both Internal and External Manufacturing teams to ensure quality expertise is integrated across all development phases.
- Lead and Mentor the CMC Quality Team: Lead and mentor the CMC Quality team and quality professionals across global operations, providing guidance and support to ensure quality excellence.
- Design and Oversee Quality Management Systems: Design and oversee the implementation of quality management systems for CMC development, including product release for GLP and GCP studies.
- Provide Quality Expertise: Provide quality expertise aligned with global quality standards for the development of product characterization, specifications, method validation, stability, and comparability assessments, particularly during technology transfers.
- Establish and Maintain Processes: Establish and maintain processes for the review and release of products for GLP and GCP studies, ensuring compliance with regulatory requirements.
- Oversee GMP Activities: Oversee GMP activities conducted by Product Development teams, CDMOs, and contract laboratories, including reviewing and approving protocols, reports, methods, and master batch records.
- Manage Supplier Qualification: Manage supplier qualification and requalification activities for CDMOs, ensuring compliance with regulatory requirements.
- Create Systems for Data Integrity: Create systems to ensure compliance with data integrity and traceability for regulatory submissions.
- Identify and Drive Improvements: Identify and drive improvements to quality processes and systems, ensuring continuous quality excellence.
- Lead the Quality Community: Lead the CMC Quality team and broader Quality community in developing, approving, and maintaining critical quality standards, focusing on minimizing product quality risks and supporting lifecycle product quality monitoring.
- Support Quality Team Members: Support Quality team members in meeting the requirements for product and process development.
Bachelor's, Master's, or PhD in a relevant field such as chemistry, pharmacy, pharmaceutical science, biology, life science, or a comparable discipline.
Required SkillsExtensive experience in the pharmaceutical industry, with a strong background in development and quality within a GxP environment. A proven track record of implementing phase-appropriate quality strategies. Direct experience in quality oversight of CDMOs. Deep knowledge of FDA and EU GMPs, especially in the context of developing, manufacturing, controlling, and distributing commercial products. A solid understanding of the drug development process and global regulatory requirements related to GxP. Expertise in small molecule manufacturing, particularly with solid oral dosage forms, with biotechnology experience being a plus. Proficiency in risk assessment and mitigation tools and processes.
