Associate Director, External Quality Operations
3 days ago
We are seeking an experienced and detail-oriented Quality professional to join our dynamic Cell Therapy team as the Associate Director, External Quality Operations. This role is responsible for ensuring the integrity and completeness of batch release documentation, including compiling and reviewing all relevant documents such as fully reviewed batch records, test results, certificates of analysis or conformance, shipping and storage documentation, and other critical documents. The ideal candidate will have a thorough understanding of regulatory requirements and cGMP standards to ensure that all products meet the highest quality standards.
Key Responsibilities
• Compile, review, and approve all necessary documentation required for the release of final products, ensuring compliance with cGMP, regulatory requirements, and company standards.
• Ensure that all batch records are complete, accurate, and fully reviewed prior to release.
• Verify and approve certificates of analysis, certificates of conformance, and other relevant documents to confirm product compliance with specifications and regulatory requirements.
• Review shipping and storage documentation to ensure that products have been handled and stored in accordance with all applicable guidelines.
• Collaborate with internal teams, including Quality Control, Manufacturing, and Regulatory Affairs, as well as external partners, to resolve any issues related to batch release.
• Stay updated with current regulatory requirements and industry best practices to ensure compliance and continuous improvement of the batch release process.
• Investigate and resolve any discrepancies or issues identified during the documentation review process.
Requirements
• Bachelor's degree and 8-12 years of related pharmaceutical/biopharmaceutical work experience, or master's degree and 6-8 years of work experience.
• Minimum of 3 years in management / leadership positions in a cGMP environment.
• Experience with batch record review and product release processes.
• Strong knowledge of cGMP regulations, particularly related to cell and gene therapy products.
Preferred Qualifications
• In-depth working knowledge of cGMP Quality Systems (change management, discrepancy management, corrective and preventive measures, and validation).
• Demonstrated ability to manage cross-functional teams and inspire collaboration across the business.
• Previous experience in commercial manufacturing and aseptic processing a plus.
• Preferred experience in cell and/or gene therapy operations and contract manufacturing.
What We Offer
Pierre Fabre offers a competitive benefits package, including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more. Our hybrid work policy, generous PTO policy, and company holidays provide a great work-life balance. We also offer paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs.
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