Vice President, Quality
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$315,000 - $371,000 USD yearly
Operations
Responsibilities
- Embed a company-wide culture of quality, accountability, and continuous improvement; model high standards and reinforce quality across functions.
- Develop and communicate a holistic Quality strategy supporting the shift from clinical development to commercial.
- Anticipate regulatory, operational, and market needs; build a proactive, risk-based Quality framework balancing innovation with compliance.
- Apply deep clinical GCP and commercial GMP expertise (late-stage development, tech transfer, scale-up, supply chain quality, lot release, QP requirements, post-market requirements with global partners).
- Oversee external partners (CMOs/CROs/vendors) via governance, audits, and performance monitoring; manage complex manufacturing networks.
- Lead/maintain inspection readiness; lead successful regulatory inspections and remediate gaps.
- Ensure quality system design, approval, and health (with IT); oversee deviations/investigations, supplier quality, QP release, and document control.
- Develop quality processes/systems/metrics for a fast-growing organization; partner cross-functionally to ensure GxP and local/global compliance.
- Build and lead a high-performing QA organization; mentor talent and foster cross-functional collaboration.
- Own Quality budgets and partner on LRP scenario modeling.
Qualifications
- BS in life sciences/chemistry/engineering or related; MBA or MS strongly preferred.
- 15+ years progressive quality experience; proven leadership building QA in pre-commercial/early commercial environments.
- Extensive knowledge of FDA/EMA regulations, quality systems, inspections, and audits.
- Experience leading regulatory inspections (clinical and commercial).
- Expertise managing CMOs/CROs/vendors; KPI accountability; preferred experience with tech transfers, batch release, stability, and PPQ.
- Ability to operate strategically and operationally in fast growth/ambiguity.
- Strong financial acumen; effective executive/BOD-level communication and cross-functional leadership.
- Decisive, risk-aware, quality-first mindset; transparent collaborator; passion for talent development and succession planning.
- Embed a company-wide culture of quality, accountability, and continuous improvement; model high standards and reinforce quality across functions.
- Develop and communicate a holistic Quality strategy supporting the shift from clinical development to commercial.
- Anticipate regulatory, operational, and market needs; build a proactive, risk-based Quality framework balancing innovation with compliance.
- Apply deep clinical GCP and commercial GMP expertise (late-stage development, tech transfer, scale-up, supply chain quality, lot release, QP requirements, post-market requirements with global partners).
- Oversee external partners (CMOs/CROs/vendors) via governance, audits, and performance monitoring; manage complex manufacturing networks.
- Lead/maintain inspection readiness; lead successful regulatory inspections and remediate gaps.
- Ensure quality system design, approval, and health (with IT); oversee deviations/investigations, supplier quality, QP release, and document control.
- Develop quality processes/systems/metrics for a fast-growing organization; partner cross-functionally to ensure GxP and local/global compliance.
- Build and lead a high-performing QA organization; mentor talent and foster cross-functional collaboration.
- Own Quality budgets and partner on LRP scenario modeling.
Qualifications
- BS in life sciences/chemistry/engineering or related; MBA or MS strongly preferred.
- 15+ years progressive quality experience; proven leadership building QA in pre-commercial/early commercial environments.
- Extensive knowledge of FDA/EMA regulations, quality systems, inspections, and audits.
- Experience leading regulatory inspections (clinical and commercial).
- Expertise managing CMOs/CROs/vendors; KPI accountability; preferred experience with tech transfers, batch release, stability, and PPQ.
- Ability to operate strategically and operationally in fast growth/ambiguity.
- Strong financial acumen; effective executive/BOD-level communication and cross-functional leadership.
- Decisive, risk-aware, quality-first mindset; transparent collaborator; passion for talent development and succession planning.