Vice President, Head of Quality Assurance

Treeline Biosciences•Watertown, MA

20d

About The Position

The Vice President, Head of Quality Assurance provides strategic and operational leadership for GxP quality across manufacturing, laboratory, distribution, pharmacovigilance, and external partner activities, from early clinical development through product approval. The role leads the development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks supporting CMC development, clinical manufacturing, and inspection readiness, with the capacity to scale as programs advance toward registration and approval. The VP partners with CMC, Clinical Operations, Regulatory, Biomarkers, Safety, Clinical, and external CDMO, CRO, and laboratory partners to ensure compliance with applicable global regulations and foster quality, integrity, patient safety, and data integrity. The position also manages Quality resources and budget and supports cross-functional project teams. The role is classified as exempt. For candidates working in Watertown, Massachusetts, the anticipated annual base salary range is $285,000–$350,000; the final offer depends on factors including experience and education, and the range may differ for other locations.

Requirements

BA/BS in Science, Engineering, or a related discipline.
15+ years of Quality Assurance experience in an FDA-regulated biotech or pharmaceutical environment, with increasing 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 supporting a clinical-stage pharmaceutical company.
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 managing OOS/OOT matters.
Expertise performing and managing Quality audits and regulatory inspections.
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 technical acumen to partner with CMC, Regulatory, Clinical Operations, Supply Chain, and other stakeholders.
Excellent written and verbal communication skills, executive presence, and ability to influence at all organizational levels.
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.

Nice To Haves

Advanced degree (MS, PhD, PharmD, or equivalent).
Experience with late-stage development, NDA/MAA submissions, and pre-approval inspections.
Working knowledge of oncology drug development.

Responsibilities

Serve as executive owner of Quality, set strategy and priorities aligned with company objectives and development milestones, and represent Quality across the organization.
Build, lead, and develop a Quality Assurance organization to support global manufacturing, laboratory, and clinical activities and scale with program advancement.
Own and develop a phase-appropriate, scalable Quality Management System that meets applicable global GxP requirements and industry standards, including management review and quality council governance.
Establish a pragmatic, data-driven Quality strategy, governance frameworks, escalation pathways, and quality metrics to enable proactive risk management and informed decisions.
Provide quality oversight of CDMOs and contract laboratories, including supplier qualification, quality agreements, audits, and performance management.
Plan, oversee, and complete risk-based audits of manufacturing, laboratory, distribution, clinical vendor, and clinical site partners.
Lead external Health Authority inspections, internal audits, inspection readiness, and preparation for pre-approval inspections.
Review and approve analytical documentation, including methods, validation protocols and reports, specifications, and stability protocols and reports; manage expiry extensions.
Provide Quality input on CMC activities, including process development, technology transfer, manufacturing scale-up, equipment qualification, process validation, and PPQ strategy.
Account for final release or other disposition of clinical trial material, including country-specific release requirements and collaboration with Qualified Persons.
Ensure timely oversight and resolution of deviations, investigations, OOS/OOT results, CAPAs, change controls, and product complaints, with relevant departmental input on Quality impact.
Review and approve clinical product labels and Quality aspects of IMPD/IND/NDA CMC sections.
Oversee Quality aspects of clinical supply chain and GDP distribution, including temperature control, storage, shipping, and returns.
Oversee pharmacovigilance Quality activities to support 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, computerized system validation, and data integrity standards.
Author, review, and approve SOPs, policies, and controlled Quality documentation.
Monitor global health authority laws, regulations, and guidance; identify gaps and implement improvements in response to new or revised requirements.
Anticipate Quality requirements for later-stage development, registration, and approval, and plan systems and resources 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.