Vice President, Head of Quality Assurance

Treeline Biosciences•Watertown, MA

22d•$285,000 - $350,000

About The Position

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. The role leads the continued development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks supporting CMC development, clinical manufacturing, and inspection readiness, while preparing the organization 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 promote quality, integrity, patient safety, and data integrity. The role builds and leads the Quality organization, owns the Quality Management System and quality strategy, oversees vendors and clinical quality activities, supports CMC and clinical supply operations, and manages Quality resourcing and budget.

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 that supports 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.
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 technical acumen to partner effectively with CMC, Regulatory, Clinical Operations, Supply Chain, and other stakeholders.
Excellent written and verbal communication skills, executive presence, and 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.

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 the executive owner of Quality, set strategy and priorities in line with company objectives and development milestones, and represent Quality across the organization.
Build, lead, and develop a Quality Assurance organization supporting growing global manufacturing, laboratory, and clinical activities.
Own and develop a phase-appropriate, scalable Quality Management System that adheres to applicable global GxP requirements and industry standards, including management review and quality council governance.
Define and drive a pragmatic, data-driven Quality strategy, establishing governance frameworks, escalation pathways, and quality metrics for proactive risk management and informed decision-making.
Provide quality oversight of CDMOs and contract laboratories, including supplier qualification, quality agreements, audit programs, and performance management.
Plan, oversee, and complete risk-based audits of manufacturing, laboratory, and distribution partners, clinical vendors, and sites.
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; 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.
Hold accountability for final release or other disposition of clinical trial material, including country-specific release requirements and collaboration with Qualified Persons.
Ensure effective oversight and timely resolution of deviations, investigations, OOS/OOT results, CAPAs, change controls, and product complaints, with relevant departmental input.
Review and approve clinical product labels and 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.
Author, review, and approve SOPs, policies, and controlled quality documentation.
Monitor global health authority laws, regulations, and guidance; identify gaps and implement process improvements arising from new or revised requirements.
Anticipate quality requirements for later-stage development, registration, and approval, and plan systems and resourcing 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.