Senior Director / Director - CMC/GMP Quality Assurance
$235,000–$285,000 year
HybridPalo Alto, California, United States
Job Summary
Maintain GMP quality assurance systems and policies for commercial and clinical injectable products, overseeing quality audits, design controls, and pre-approval inspections at CMOs and CDMOs. Manage the review and approval of manufacturing batch records, process validations, and deviation investigations, including out-of-specifications and temperature excursions. Support supply chain, distribution, and product return dispositions while ensuring compliance with FDA CDER and CDRH regulations for regulatory submissions. Conduct routine and for-cause audits of vendors, 3PL providers, and contract manufacturers to verify inspection readiness and close out findings.
Required Qualifications
- Minimum bachelor's degree in relevant scientific or engineering discipline or equivalent
- Minimum of 15 + years of CMC/GMP Quality Assurance (GMP QA) and QMS related prior experience in commercial injectable product manufacturing, combination injectable product manufacturing or clinical injectable product manufacturing and design controls at a Pharmaceutical or Biotechnology Company
- Prior experience in Quality Management Systems, Quality Compliance, Quality Audits and Design Controls for commercial product/combination product pipelines is a must
- FDA pre-approval inspections and GMP inspections is a must
- CMC QA experience with commercial combination products is a must
- Review/authoring of CMC reports and associated regulatory filings to FDA-CDER-NDA (Part 210/211) and FDA-CDRH-PMA (Part 820) is a must
- Quality Compliance for Aseptic Product Manufacturing, Combination Injectable Product Manufacturing, and/or Process Performance Qualification and Analytical Testing of commercial injectable products or late stage clinical products is a must
- Design control, design verification, risk management and design history files for combination injectable products is a must
- Working with CDMO, vendors, and 3PL-supply chain/distribution/return of commercial products is a must
- Knowledge of cGMP, ICH Guidelines, FDA CDER, and FDA CDRH Regulations, ICH Guidelines and Iso Guidelines for drug substance, drug products, injectable drug products, combination products, and/or medical devices is required, as applicable
Desired Qualifications
- Prior experience in Quality Management Systems, Quality Compliance, Quality Audits and Design Controls for clinical product pipelines is a plus
- Working with CMO, vendors, and 3PL-supply chain/distribution/return of late stage clinical products is a plus
- Review/authoring of CMC reports, Design Controls and Device reports and associated regulatory filings to FDA-CDER-NDA (Part 210/211) and FDA-CDRH-PMA (Part 820) is a plus
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