Senior Director, GMP Quality Operations & Supplier Quality
Bicara Therapeutics Inc - Boston, MA, United States
Posted Apr 28, 2026
Benefits
- Parental leave
- Not verified
- Non-birth-parent leave
- Not verified
- Family-building benefits
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- Fertility benefits: Not verified
- Adoption assistance: Not verified
- Surrogacy assistance: Not verified
- Mental health support
- Not verified
- Relocation assistance
- Not verified
- Childcare support
- Not verified
- Learning budget
- Not verified
- Verification
- Not verified checked Jun 13, 2026
- Salary
- Not verified
- 401(k) match
- Reported from DOL Form 5500 industry filing (not employer-specific)
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Market context
- U.S. role benchmark (BLS OEWS)
- $61,842 U.S. median for this role
- Projected growth (BLS Employment Projections)
- +1.9% - Slower
Matched to SOC 11-1021 - Operations aggregate by role bucket.
Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.
Role
Schedule
- Shift type
- Not verified
- Weekend work
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Company
Application
- Cover letter
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- Assessment
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- Deadline
- Not stated
Where they hire
State eligibility is not yet verified.
About this role
Senior Director, GMP Quality Operations & Supplier Quality Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Senior Director, GMP Quality & Supplier Quality to provide leadership and oversight of GMP Quality operations supporting external manufacturing, quality control, packaging and labeling, QP release, and global distribution. This role is critical to ensuring sustained inspection readiness as the organization advances through Phase 3, regulatory submission, and commercialization. The position will initially focus on clinical supply through external partners and will play a key role in building scalable Quality processes to support commercial readiness, including batch disposition, QP release, and global supply oversight. Operating within a matrixed global Quality organization, this role requires a balance of strategic leadership and hands-on execution, with strong cross-functional collaboration across Technical Operations, Quality Systems, and external partners. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - 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
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