Vice President, Quality

About the role

Bicara Therapeutics is looking for a Vice President, Quality to join its leadership team in Boston. The role combines strategic vision with hands‑on execution, guiding the company through the transition from clinical development to commercial manufacturing while ensuring product integrity, patient safety, and regulatory compliance.

Key responsibilities

• Define and communicate a holistic Quality strategy aligned with corporate goals and the shift to commercial production.
• Embed a company‑wide culture of quality, accountability, and continuous improvement.
• Lead clinical GCP and commercial GMP operations, including tech transfer, scale‑up, supply‑chain quality, lot release, and QP responsibilities.
• Oversee external partners (CMOs, CROs, vendors) through governance, audits, and performance monitoring.
• Maintain inspection readiness, lead regulatory inspections, and remediate gaps.
• Design, approve, and sustain quality systems in partnership with IT, covering batch disposition, deviation management, supplier quality, and document control.

Required profile

• Extensive senior‑level experience in both clinical and commercial quality environments for biologics.
• Proven ability to operate in a resource‑lean, fast‑growing biotech setting.
• Strong leadership presence with a track record of building and scaling quality functions.
• Deep knowledge of global regulatory expectations for commercial biologics.

Required skills

• Good Clinical Practice (GCP) compliance
• Good Manufacturing Practice (GMP) compliance
• Tech transfer and scale‑up expertise
• Supply‑chain quality management
• Lot release and Qualified Person (QP) responsibilities
• Post‑market quality oversight
• Regulatory inspection preparation and remediation
• Quality systems design and document control