Overview
I’m partnering with a clinical-stage biotechnology company developing first-in-class antibody therapies that target signal regulatory proteins (SIRP) for the treatment of severe immunological diseases and cancer . They’re seeking a Director, GMP Quality Assurance (QA) to lead quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical materials. This role will be a key cross-functional partner, working closely with CMC, Supply Chain, and Regulatory teams to drive quality strategy and operational excellence.
Base pay
Base pay range: $170,000.00/yr - $240,000.00/yr
Responsibilities
- Oversee QA for all GxP operations conducted by external partners, including CDMOs and testing labs
- Ensure timely batch record review, product disposition, and compliance with regulatory requirements
- Develop and monitor partner performance metrics, risk assessments, and escalation pathways
- Collaborate with internal CMC, Regulatory, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
- Lead cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
- Champion a culture of quality and inspection readiness across internal and external operations
Qualifications
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field
- 8-10+ years of CGMP Quality Assurance experience, including biologics manufacturing and analytical testing
- Direct experience managing external partners/CDMOs and ensuring compliance from clinical to commercial supply
- Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance
How to apply
If interested, apply now or contact Kelly Komon at
Benefits and EEO
Benefits provided by Meet Recruitment.
Equal Opportunity Employer: Equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex, or any other status protected by federal, state or local laws where in operation.
Job details
- Seniority level: Director
- Employment type: Full-time
- Job function: Quality Assurance
- Industries: Biotechnology Research and Pharmaceutical Manufacturing