Director, Quality Control
Director, Quality Control
Location: Seattle, WA (Onsite)
Overview
EPM Scientific is partnered with a growing biotechnology company to hire a Director, Quality Control. Our client is seeking a strategic QC leader to oversee quality control activities across both clinical and commercial programs while leading a growing team of scientists. This individual will be responsible for developing QC strategy, supporting analytical and manufacturing initiatives, and ensuring quality control operations are positioned to support the company's continued growth and regulatory objectives.
Key Responsibilities
- Lead Quality Control activities supporting clinical and commercial products, including in-process and release testing of GMP materials
- Manage, mentor, and develop QC personnel while supporting continued team growth
- Oversee stability programs, including planning, execution, data analysis, and shelf-life determination strategies
- Provide QC oversight for external manufacturing and testing partners to ensure cGMP compliance
- Oversee product release specifications, certificate of analysis generation, and batch record review activities
- Partner with Technical Operations and CMC teams to develop QC strategy aligned with analytical and manufacturing needs
- Support analytical method transfer, qualification, and validation activities with internal and external partners
- Establish and maintain quality control standards across all stages of product development and commercialization
- Contribute to regulatory filings, inspections, and health authority interactions
- Drive continuous improvement initiatives across QC operations and systems
Requirements
- PhD in Analytical Chemistry, Biochemistry, Biology, or a related scientific discipline
- 10+ years of Quality Control experience within biotechnology or pharmaceutical environments
- Strong background supporting both clinical and commercial programs; biologics experience preferred, with small molecule experience a plus
- Deep understanding of GMP regulations, ICH guidelines, and quality systems
- Experience with analytical method development, validation, and technology transfer
- Experience supporting stability programs, regulatory inspections, and health authority interactions
- Prior people leadership experience with strong communication and stakeholder management skills
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