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 validation, and data integrity standards across the organization.
• Author, review, and approve SOPs, policies, and controlled quality documentation.
• Keep current with global health authority laws, regulations, and guidance; identify gaps and implement process improvements resulting from new or revised requirements.
• Anticipate quality requirements for later-stage development, registration, and approval, and plan systems and resourcing accordingly so the Quality Management System can scale without rework.
• Manage the Quality budget and resourcing, and participate in project teams and sub-teams as needed.

Required Qualifications

• BA/BS in Science, Engineering, or a related discipline required; advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• 15+ years of Quality Assurance experience in an FDA-regulated biotech or pharmaceutical environment, with increasing levels of responsibility, including leadership of a quality function.
• 5+ years of hands-on experience in one or more technical disciplines before transitioning into QA: Chemical Development/Manufacturing, Drug Product Development/Manufacturing, or Analytical Development.
• Demonstrated success building and leading a quality organization that supports a clinical-stage pharmaceutical company.
• Demonstrated success supporting programs through clinical development; experience with late-stage development, NDA/MAA submissions, and pre-approval inspections is a plus.
• Mastery of global GxP requirements and applicable international regulations and guidelines.
• Deep expertise in batch review and disposition for clinical-phase products.
• Expertise authoring and reviewing SOPs, deviations, investigations, CAPAs, and change controls, and in OOS/OOT management.
• Expertise performing and managing Quality audits and regulatory inspections.
• Demonstrated understanding of issue management, risk management, and CAPA effectiveness in manufacturing, laboratory, and clinical environments.
• Expertise overseeing quality aspects of global vendor networks, including CDMOs, contract laboratories, and distribution partners.
• Working knowledge of data integrity and computerized system validation requirements.
• Strong collaboration skills and sufficient technical acumen to partner effectively with CMC, Regulatory, Clinical Operations, Supply Chain, and other key stakeholders.
• Excellent written and verbal communication skills, with strong executive presence and the ability to influence at all levels of the organization.
• Ability to manage competing priorities and timelines in a fast-paced, evolving environment.
• Strong problem-solving skills and ability to implement scalable Quality Systems improvements.
• Demonstrated commitment to quality, compliance, patient safety, and data integrity.
• Working knowledge of oncology drug development preferred.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $285,000 - $350,000. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.