What are the responsibilities and job description for the Director of Quality Assurance position at Barrington James?
Director, External Quality Assurance (GMP)
Remote position but must be located on the West Coast.
Must have relevant experience with Monoclonal Antibodies or Bispecific Antibodies.
About the Role
A clinical-stage biopharmaceutical company is seeking a Director of External Quality Assurance (GMP) to lead quality oversight for external manufacturing and testing partners.
This role will ensure that outsourced activities meet GMP, regulatory, and company standards while supporting the reliable delivery and release of clinical products.
Key Responsibilities
- Lead GMP quality oversight for external manufacturers, testing laboratories, and other vendors
- Support product release and review manufacturing and testing documentation
- Manage vendor quality relationships, performance, and compliance
- Oversee deviations, investigations, CAPAs, change controls, and root-cause analyses
- Participate in vendor audits and inspection readiness activities
- Review and approve quality agreements and technical documentation
- Partner with Manufacturing, Quality, Regulatory, Clinical Development, and other cross-functional teams
- Identify opportunities to improve external quality processes and systems
Qualifications
- Must have relevant experience with Monoclonal Antibodies or Bispecific Antibodies.
- Bachelor’s degree in science, engineering, pharmacy, or a related field; advanced degree preferred
- Significant experience in GMP Quality Assurance within the pharmaceutical or biotechnology industry
- Experience overseeing CDMOs, CMOs, contract laboratories, or other external partners
- Strong knowledge of GMP requirements, quality systems, product release, deviations, CAPA, and change control
- Experience supporting clinical-stage products and outsourced manufacturing activities
- Strong leadership, communication, organizational, and problem-solving skills
- Ability to work effectively in a cross-functional, fast-paced environment
Compensation and Benefits
The company offers a competitive compensation package, including bonus eligibility, equity participation, comprehensive benefits, and paid time off.