treelinebiosciences · 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,…
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