Vice President, Head of Quality Assurance

Vice President, Head of Quality Assurance

Watertown, Massachusetts, United States

Vice President, Head of Quality Assurance About the Role

The Vice President, Head of Quality Assurance provides strategic and operational leadership of GxP quality across manufacturing, laboratory, distribution, pharmacovigilance, and external partner activities from early clinical development through product approval. This individual will lead the continued development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support CMC development, clinical manufacturing, and inspection readiness, while building a foundation that can scale as the company’s programs advance toward registration and approval.

The VP will partner with CMC, Clinical Operations, Regulatory, Biomarkers, Safety, and Clinical, and with external CDMO, CRO, and laboratory partners, to ensure compliance with applicable global regulations and to sustain a strong culture of quality, integrity, patient safety, and data integrity.

Responsibilities

• Serve as the executive owner of quality, setting quality strategy and priorities in line with company objectives and development milestones, and representing Quality across the organization.
• Build, lead, and develop a quality assurance organization capable of supporting Treeline’s growing global manufacturing, laboratory, and clinical activities and positioned to scale as programs advance.
• Own and continue to develop Treeline’s Quality Management System in a phase-appropriate, scalable manner, ensuring adherence to applicable global GxP requirements and industry standards, including management review and quality council governance.
• Define and drive a pragmatic, data-driven Quality strategy, and establish governance frameworks, escalation pathways, and quality metrics that enable proactive risk management and informed decision-making.
• Provide quality oversight of CDMOs, contract laboratories, including supplier qualification, quality agreements, audit programs, and ongoing performance management.
• Plan, oversee, and complete audits of manufacturing, laboratory, and distribution partners, and of clinical vendors and sites through a risk-based audit program.
• Lead external Health Authority inspections, internal audits, and inspection readiness activities and build toward pre-approval inspection readiness.
• Review and approve analytical documentation, including methods, validation protocols and reports, specifications, and stability protocols and reports, and manage expiry extensions.
• Provide Quality input into CMC activities, including process development, tech transfer, manufacturing scale-up, equipment qualification, and process validation and PPQ strategy as programs mature toward registration.
• Hold accountability for final release or other disposition of clinical trial material, including country-specific release requirements and collaboration with Qualified Persons (QPs).
• Ensure effective oversight and timely resolution of deviations, investigations, OOS/OOT results, CAPAs, change controls, and product complaints, seeking input from relevant departments so that Quality impact is fully evaluated.
• Review and approve clinical product labels and the quality aspects of IMPD/IND/NDA CMC sections.
• Oversee quality aspects of the clinical supply chain and distribution (GDP), including temperature control, storage, shipping, and returns.
• Oversee pharmacovigilance quality activities to ensure compliance, data integrity, and effective safety surveillance.
• Ensure appropriate quality oversight of clinical trial execution and GCP compliance, in partnership with Clinical Operations.
• Drive consistency in quality processes, risk management approaches, computerized system…