Vice President, Quality

Responsibilities

• Embedding a company-wide culture of quality, accountability, and continuous improvement.
• Acting as a visible, influential leader who models high standards and reinforces quality as a shared responsibility across functions.
• Developing and communicating a holistic Quality strategy that supports the shift from clinical development to commercial manufacturing, aligned with the company’s goals.
• Anticipating future regulatory, operational, and market needs and ensuring the Quality function is structured to meet them.
• Building a proactive, risk-based Quality framework that balances innovation with compliance.
• Deep experience with clinical GCP & commercial GMP operations, including late-stage development, tech transfer, scale-up, supply chain quality, lot release, QP requirements and post-market requirements with global partners.
• Willingness to engage directly in critical tasks, investigations, and decisions—especially in a small, resource-lean environment.
• Meticulous attention to detail with the ability to dive into technical issues when needed.
• Knowledge of global regulatory frameworks and expectations for commercial biologics products.
• Ensuring effective oversight of CMOs, CROs, and vendors through structured governance, auditing, and performance monitoring.
• Experience managing complex external manufacturing networks.
• Proven track record leading successful regulatory inspections.
• Ability to anticipate agency expectations, remediate gaps, and maintain a continuous state of inspection readiness.
• Accountability for the design, approval, and ongoing health of the company’s quality systems in collaboration with IT.
• Oversight of quality operations, including batch disposition, deviation/investigation management, supplier quality, QP release, and document control.
• Develop and implement quality processes, systems, and performance metrics as appropriate for a fast-growing organization with aggressive clinical development plans and future commercialization vision across potentially multiple indications in oncology.
• 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.
• 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.
• Partner with Finance to support LRP scenario modeling.

Requirements

• Bachelor's degree in life sciences, chemistry, engineering, or related discipline. Advanced degree (MBA or MS) strongly preferred.
• 15+ years of progressive industry experience in quality organizations.
• Demonstrated success in building and leading quality organizations in pre-commercial and early commercial environments with domestic and internal commercial launch experience.
• 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.
• 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.
• Proven ability to operate at both strategic and operational levels in fast growth, ambiguous environments.
• Strong financial acumen, including managing effective multimillion budgets and COGs optimization.
• Track record of effective executive and BOD level communication, influence, and cross functional leadership.
• 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.