Director GMP Quality Assurance
$100 - $125 per hourScientific Search
Director, GMP Quality Assurance Location : Remote Employment Type : Contract (9-12 months+) Hourly Rate - $100-125HR Scientific Search has partnered with an innovative biotechnology organization seeking an experienced Director, GMP Quality Assurance to provide strategic and operational QA leadership supporting biologics manufacturing, analytical testing, stability programs, and external partner oversight. This individual will play a key role in ensuring GMP compliance, supporting quality systems, and driving cross-functional collaboration across manufacturing, quality control, regulatory, and supply chain activities within a fast-paced clinical-stage environment. Responsibilities Manufacturing & Analytical QA Oversight
- Provide GMP QA oversight for drug substance and drug product manufacturing activities conducted at external CMOs, including batch record review and approval
- Review and approve GMP analytical methods, test protocols, and associated documentation generated at external contract laboratories
- Provide quality partnership and oversight for biologics manufacturing, testing, and product disposition activities, including combination products
- Provide QA oversight of stability programs for drug substance and drug product activities, including review and approval of stability protocols, reports, and supporting data
- Partner with Clinical QC teams to ensure stability study design and execution align with ICH guidelines and applicable regulatory commitments
- Oversee QA activities related to reference standard qualification, characterization, and requalification
- Review and approve reference standard protocols and reports while ensuring proper chain of custody, storage, and release documentation
- Support compliance within Quality Management Systems and external CDMO manufacturing/testing operations in accordance with FDA and global GMP regulations, including 21 CFR Parts 4, 210, 211, 820 and EU GMP guidelines
- Collaborate cross-functionally with CMC, Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations, and Supply Chain teams
- Review and verify quality-related documents, records, protocols, reports, and data supporting biologics programs and products
- Identify, assess, and escalate quality risks while driving compliant resolutions and continuous quality improvement initiatives
- Contribute to the development and refinement of quality processes, procedures, and organizational quality culture
- Bachelor’s degree in scientific discipline or related field required
- 10–15 years of progressive GMP Quality Assurance experience within biotech, pharmaceutical, or biologics environments
- Strong experience overseeing external CDMO/CTO manufacturing and testing operations
- Hands-on expertise supporting QA oversight of QC operations, manufacturing, analytical testing, and supply chain activities
- Strong working knowledge of FDA and global GMP regulations and quality systems
- Experience supporting biologics and/or combination products strongly preferred
- Excellent communication, collaboration, and problem-solving skills within matrixed organizations
- Ability to support occasional evening meetings based on business needs
Vacancy posted 3 hours ago
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