Senior Director, GMP Operations, Supplier Quality

Bicara Therapeutics

. Provide end-to-end Quality oversight of CDMOs, contract laboratories, and packaging/labeling vendors supporting clinical and future commercial supply.

Posted 4/29/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $259,000 - $297,000 per yearWebsite

About the role

Key responsibilities & impact

Provide end-to-end 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 the development and maturation 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.
Partner with Quality Systems to ensure external manufacturing processes are fully integrated into core QMS elements, including deviations, CAPA, change control, and product complaints.
Develop and implement scalable, phase-appropriate Quality processes to support transition from clinical to commercial operations.

Requirements

What you’ll need

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 and participating in 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.
Certification in quality assurance (e.g., Certified Quality Auditor) is desirable.

Benefits

Comp & perks

health insurance
dental coverage
vision coverage upon hire
flexible work arrangements
short term and long-term incentives including cash bonus and equity incentive opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GMP Quality experienceQuality oversightBatch dispositionQP releasePPQCAPAChange controlDeviation managementRegulatory inspectionsQuality processes

Soft Skills

LeadershipCollaborationProblem-solvingCommunicationOperationalization

Certifications

Bachelor’s degree in life sciencesCertified Quality Auditor