Senior Director, GMP Quality Operations & Supplier Quality
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$259,000 - $297,000 USD yearly
Operations
Responsibilities:
- Provide end-to-end GMP Quality oversight of CDMOs, contract laboratories, and packaging/labeling vendors supporting clinical and future commercial supply.
- Lead supplier qualification, performance management, and establishment of robust Quality Agreements.
- Ensure effective oversight and timely resolution of deviations, investigations, CAPAs, and change controls across external partners.
- Establish and implement scalable, end-to-end batch disposition processes aligned with global regulatory expectations.
- Build and operationalize QP release frameworks in collaboration with EU Qualified Persons and external manufacturers.
- Partner with Technical Operations and CDMOs to support PPQ readiness and execution, ensuring alignment on Quality expectations.
- Contribute to development of the commercial manufacturing and distribution model, including supply chain readiness.
- Lead and support inspection readiness activities, including preparation for regulatory inspections across FDA, EMA, PMDA, and other global authorities.
- Integrate external manufacturing processes into core QMS elements (deviations, CAPA, change control, and product complaints).
- Develop and implement scalable, phase-appropriate Quality processes to transition from clinical to commercial operations.
- Foster a Quality culture grounded in problem solving, risk management, continuous improvement, and business partnership.
Qualifications:
- Bachelor’s degree in life sciences or related industry experience.
- 10+ years of GMP Quality experience in biotech/pharma.
- Experience with external manufacturing and supplier Quality oversight; CMDO experience desired.
- Direct experience supporting global regulatory inspections, including pre-approval inspections.
- Strong knowledge of GMP regulations (FDA, EMA, ICH); GDP and global distribution experience preferred.
- Experience with batch disposition, QP release, PPQ, and commercial supply readiness.
- Excellent communication and interpersonal skills; ability to collaborate across departments and external stakeholders.
- Detail-oriented with proactive problem-solving and decision-making.
- Certification in quality assurance (e.g., Certified Quality Auditor) desirable.
- Provide end-to-end GMP Quality oversight of CDMOs, contract laboratories, and packaging/labeling vendors supporting clinical and future commercial supply.
- Lead supplier qualification, performance management, and establishment of robust Quality Agreements.
- Ensure effective oversight and timely resolution of deviations, investigations, CAPAs, and change controls across external partners.
- Establish and implement scalable, end-to-end batch disposition processes aligned with global regulatory expectations.
- Build and operationalize QP release frameworks in collaboration with EU Qualified Persons and external manufacturers.
- Partner with Technical Operations and CDMOs to support PPQ readiness and execution, ensuring alignment on Quality expectations.
- Contribute to development of the commercial manufacturing and distribution model, including supply chain readiness.
- Lead and support inspection readiness activities, including preparation for regulatory inspections across FDA, EMA, PMDA, and other global authorities.
- Integrate external manufacturing processes into core QMS elements (deviations, CAPA, change control, and product complaints).
- Develop and implement scalable, phase-appropriate Quality processes to transition from clinical to commercial operations.
- Foster a Quality culture grounded in problem solving, risk management, continuous improvement, and business partnership.
Qualifications:
- Bachelor’s degree in life sciences or related industry experience.
- 10+ years of GMP Quality experience in biotech/pharma.
- Experience with external manufacturing and supplier Quality oversight; CMDO experience desired.
- Direct experience supporting global regulatory inspections, including pre-approval inspections.
- Strong knowledge of GMP regulations (FDA, EMA, ICH); GDP and global distribution experience preferred.
- Experience with batch disposition, QP release, PPQ, and commercial supply readiness.
- Excellent communication and interpersonal skills; ability to collaborate across departments and external stakeholders.
- Detail-oriented with proactive problem-solving and decision-making.
- Certification in quality assurance (e.g., Certified Quality Auditor) desirable.