Senior Director, GMP Quality Operations & Supplier Quality

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 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.

• Foster a strong 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 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.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.

• Detail-oriented mindset with a proactive approach to problem-solving and decision-making.

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

Company Overview

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.