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Salary: USD 285,000 - 350,000 / annual
Treeline Biosciences seeks a Vice President, Head of Quality Assurance to provide strategic and operational leadership of GxP quality across manufacturing, laboratory, distribution, pharmacovigilance, and external partner activities from early clinical development through product approval.
You will lead the development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support CMC development, clinical manufacturing, and inspection readiness. You will build a foundation capable of scaling as the company's programs advance toward registration and approval.
Key responsibilities include:
- Serve as executive owner of quality, setting strategy and priorities aligned with company objectives and development milestones
- Build, lead, and develop a quality assurance organization supporting growing global manufacturing, laboratory, and clinical activities
- Own and develop Treeline's Quality Management System in a phase-appropriate, scalable manner, ensuring adherence to global GxP requirements and industry standards
- Define and drive a pragmatic, data-driven Quality strategy with governance frameworks, escalation pathways, and quality metrics enabling proactive risk management
- Provide quality oversight of CDMOs and contract laboratories, including supplier qualification, quality agreements, audit programs, and performance management
- Plan, oversee, and complete audits of manufacturing, laboratory, distribution partners, and clinical vendors through a risk-based audit program
- Lead external Health Authority inspections, internal audits, and inspection readiness activities
- Review and approve analytical documentation, including methods, validation protocols, specifications, and stability protocols
- Provide Quality input into CMC activities including process development, tech transfer, manufacturing scale-up, and process validation
- Hold accountability for final release or disposition of clinical trial material, including country-specific release requirements
- Ensure effective oversight and timely resolution of deviations, investigations, OOS/OOT results, CAPAs, change controls, and product complaints
- Review and approve clinical product labels and quality aspects of IMPD/IND/NDA CMC sections
- Oversee quality aspects of 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
- Keep current with global health authority laws, regulations, and guidance; identify gaps and implement process improvements
- Anticipate quality requirements for later-stage development, registration, and approval; plan systems and resourcing accordingly
- Manage Quality budget and resourcing; participate in project teams as needed
You will partner with CMC, Clinical Operations, Regulatory, Biomarkers, Safety, and Clinical teams, as well as external CDMO, CRO, and laboratory partners, to ensure compliance with applicable global regulations and sustain a strong culture of quality, integrity, patient safety, and data integrity.
REQUIREMENTS:
- BA/BS in Science, Engineering, or 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 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
