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AD/Director, GMP Quality Assurance
172877
Posted:
21/08/2025
- 170000 USD - 240000 USD
- South San Francisco, United States
- Permanent
Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.
We are seeking an experienced and collaborative Associate Director/Director of GMP Quality Assurance to lead quality of our outsourced manufacturing and testing operations. This role is a key quality leader and cross-functional partner—working closely with CMC, Supply Chain, and Regulatory teams—to ensure product quality, compliance, and timely supply of clinical materials. You will drive quality strategy, build scalable systems, and foster strong partnerships across internal and external stakeholders. This is an exciting opportunity to make a broad and meaningful impact in a high-growth environment.
KEY RESPONSIBILITIES:
EDCUATION & PROFESSIONAL EXPERIENCE:
The salary range for this position is $170,000 - $240,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.
We are seeking an experienced and collaborative Associate Director/Director of GMP Quality Assurance to lead quality of our outsourced manufacturing and testing operations. This role is a key quality leader and cross-functional partner—working closely with CMC, Supply Chain, and Regulatory teams—to ensure product quality, compliance, and timely supply of clinical materials. You will drive quality strategy, build scalable systems, and foster strong partnerships across internal and external stakeholders. This is an exciting opportunity to make a broad and meaningful impact in a high-growth environment.
KEY RESPONSIBILITIES:
- Oversee QA activities for all GxP operations conducted by external partners, ensuring product quality, compliance, and business continuity.
- Ensure timely batch record review and disposition across all programs to meet clinical and commercial supply demands.
- Develop robust monitoring systems for external partner performance, including KPIs, risk assessments, and escalation pathways.
- Cultivate high-impact, collaborative relationships with CDMOs and CTLs to drive a culture of quality and operational excellence.
- Partner with internal CMC, Regulatory, and Supply Chain to support technical transfers, process development, and regulatory submissions (e.g., INDs, BLAs).
- Represent QA in governance discussions and contribute to cross-functional risk assessments and strategic planning efforts.
- Ensure external partners maintain a state of inspection readiness and are aligned with evolving regulatory requirements.
- Contribute to regulatory strategy by reviewing and approving key CMC documentation and regulatory submissions (e.g., INDs, BLAs).
- Lead cross-functional initiatives to strengthen quality processes, enhance compliance, and drive operational efficiency.
- Champion a culture of quality, promoting a mindset of ownership, continuous learning, and proactive risk management across internal and external operations.
EDCUATION & PROFESSIONAL EXPERIENCE:
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field.
- 8-10+ years of CGMP Quality Assurance experience (biologics experience needed). Knowledge in clinical development to commercial is desired (ideally phase II/III to commercial).
- Strong decision-making skills in complex supply, compliance, technical, and regulatory situations; adept at managing ambiguity.
- Hands-on experience in manufacturing, analytical testing, and development.
- Proven track record in working with suppliers and CDMOs.
- Expertise in implementing and managing Quality Management Systems, including paper-based and Celito EDMS in biotech/pharma.
- In-depth knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance.
- Experienced in developing Quality Management Systems (QMS) and enjoys interpreting regulations to build and maintain compliant systems.
- Excellent verbal and written communication skills.
- Strong collaborative, analytical, and interpretative abilities.
- Self-sufficient with the ability to prioritize and meet deadlines.
- Experience working with cross-functional teams.
The salary range for this position is $170,000 - $240,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.
Tanya Kochan
Account Manager