Bicara Therapeutics
Vice President, Quality
Boston · Exec
Sponsorship not specifiedDetected 30 days ago
GCPAuditingSupply ChainGMPFDA RegulatoryLeadershipCommunicationCollaborationMentoringGxP
About the role
- Bicara Therapeutics is seeking a Vice President, Quality to serve as a key member of the leadership team, playing a critical role in shaping the company's long-term success, regulatory readiness, and operational excellence.
- The VP, Quality serves as the chief steward of the company's quality vision, culture, and systems.
- This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
Responsibilities
- Developing and communicating a holistic Quality strategy that supports the shift from clinical development to commercial that is aligned with the company's goals.
- Building a proactive, risk‑based Quality framework that balances innovation with compliance.
- External Partner Ecosystem
- Ability to anticipate agency expectations, remediate gaps, and maintain a continuous state of inspection readiness.
- Oversight of quality operations, including batch disposition, deviation/investigation management, supplier quality, QP release, and document control.
- Partner closely with Regulatory, Technical Operations, Supply Chain, Clinical Operations, Commercial, Finance, IT, and Legal to ensure full alignment and compliance with relevant local and global regulatory requirements, including GxP and any local regional distribution requirements.
- Team Building & Organizational Development
- Ability to build, inspire, and lead a high-performing QA organization.
- Skill in developing scalable teams, mentoring talent, and fostering cross-functional collaboration.
- Own and manage Quality budgets across relevant functions and in alignment with CDPs.
Requirements
- Bachelor's degree in life sciences, chemistry, engineering, or related discipline.
- 15+ years of progressive industry experience in quality organizations.
- Extensive knowledge of regulatory requirements, Quality systems, inspections, audits, and all applicable FDA and EMA regulations.
- Experience in leading and managing regulatory inspections ideally including both clinical and commercial stage environments.
- Proven ability to operate at both strategic and operational levels in fast growth, ambiguous environments.
- Track record of effective executive and BOD level communication, influence, and cross functional leadership.
- Bachelor's degree in life sciences, chemistry, engineering, or related discipline. Advanced degree (MBA or MS) strongly preferred.
- Demonstrated success in building and leading quality organizations in pre-commercial and early commercial environments with domestic and internal commercial launch experience.
- Deep expertise managing external partners (CMOs/CROs) and complex vendor relationships with a strategic view while successfully implementing appropriate KPI mechanisms and accountability. Experience with technology transfers, batch release, stability and PPQ preferred.
- Strong financial acumen, including managing effective multimillion budgets and COGs optimization.
- Decisive, risk-aware leader with strong judgment and a Quality-first mindset.
- Collaborative, transparent communicator who builds trust across functions and with external partners.
- Passionate about talent development, succession planning, and building durable organizations.
- 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 http://www.bicara.com.
Nice to have
- Advanced degree (MBA or MS) strongly preferred.
- Experience with technology transfers, batch release, stability and PPQ preferred.
Benefits
- Accountability for the design, approval, and ongoing health of the company's quality systems in collaboration with IT.
Company info
- Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation.
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