Vice President, Head of Quality Assurance
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.&