Head of Quality Assurance

About the Role

The Head of Quality Assurance is responsible for providing strategic and operational quality assurance oversight for clinical operations, clinical development, pharmacovigilance, and manufacturing and external partner activities across all phases of drug development, product launch, and commercialization.

This individual will lead the continued development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support clinical development, inspection readiness, commercialization activities, and commercial product lifecycle management, with particular emphasis on GCP compliance and clinical trial quality oversight.

The Head of Quality will work cross-functionally with Regulatory, Clinical Operations, Clinical Development, Pharmacovigilance, and Technical Operations as well as external CROs, clinical sites, CMO/CDMOs, and PV partners, to ensure compliance with applicable global regulations and to maintain a strong culture of quality, integrity, patient safety, and data integrity.

Responsibilities

• Build, lead, and manage a quality assurance team capable of supporting the company's growing global clinical and technical development activities throughout the development continuum, including commercialization and lifecycle management.
• Provide strategic and operational oversight of the company's Quality Assurance operation, with primary focus on clinical quality and GCP compliance.
• Ensure Quality approaches appropriately support execution of clinical trials, including oversight of CROs and GCP compliance activities.
• Plan, conduct, and complete reports for clinical site, CRO, and PV vendor audits; oversee CMO/CDMO audits as needed.
• Lead external Health Authority inspections, internal audits, and inspection readiness activities with particular depth in GCP, supported by GPV and GMP functions.
• Continue to develop and maintain the company's clinical Quality Management Systems in a phase-appropriate manner, ensuring adherence to applicable global regulatory requirements (FDA, EMA, ICH E6(R2/R3), and other relevant GCP guidance) and industry standards.
• Author, review, and revise clinical quality SOPs, policies, and controlled quality documentation.
• Define and drive a pragmatic, data-driven, phase-appropriate clinical Quality strategy aligned with company objectives and development milestones.
• Establish governance frameworks, escalation pathways, and quality metrics to enable proactive risk management and informed decision-making across clinical programs.
• Provide Quality oversight of external CRO, clinical site, and PV vendor networks; provide Quality oversight of manufacturing, laboratory, packaging, labeling, and distribution partners as needed.
• Oversee pharmacovigilance quality activities and vendor oversight to ensure compliance, data integrity, and effective safety surveillance.
• Ensure effective oversight and timely resolution of clinical quality issues, deviations, investigations, CAPAs, change controls, and product complaints, including protocol deviations, informed consent issues, and site-level findings, seeking input from relevant departments to ensure fully informed evaluations of quality impact.
• Review and approve clinical protocols, informed consent forms, and clinical quality aspects of IMPD/IND submissions.
• Review and approve clinical product labels.
• Responsible for final release or other disposition of clinical trial material, including country-specific release requirements and collaboration with Qualified Persons (QPs), in partnership with Technical Operationsmanufacturing quality.
• Provide Quality input into manufacturing scale-up and validation strategies as they intersect with clinical supply, and commercial readiness initiatives.
• Oversee batch record review (Executed and Master) and analytical documentation as needed to support clinical trial material release.
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization.
• Keep current with global health authority laws and regulations, particularly GCP-related; identify gaps and implement process improvements resulting from new or revised regulations or guidance.
• Participate in project teams and sub-teams as needed.

Required Qualifications

• BA/BS in Science, Engineering, or related discipline required; advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• Minimum of 10+ years of Quality Assurance experience in an FDA-regulated Biotech or Pharmaceutical environment with increasing levels of responsibility, with substantial experience in clinical/GCP quality.
• Minimum of 5 years of hands-on experience in one or more of the following partner disciplines before transferring into a QA role: Clinical Trial Management, Clinical Operations, Chemical/Drug Product Development or Manufacturing, Analytical Development.
• Demonstrated success in building and leading a clinical quality organization capable of supporting a clinical/early commercial small pharmaceutical company.
• Demonstrated success in supporting programs from clinical development through commercial readiness and lifecycle management.
• Mastery of global GxP requirements, with deep expertise in GCP (ICH E6, FDA, EMA) and working knowledge of GCLP, GPV, cGMPs, and applicable international regulations and guidelines.
• Expertise overseeing quality aspects of global vendor networks, particularly CROs and clinical sites, and pharmacovigilance vendors; working knowledge of CMO/CDMO oversight.
• Expertise authoring and reviewing clinical SOPs, deviations, CAPAs, investigations, and change controls.
• Expertise performing and managing GCP-focused Quality audits and Health Authority inspections (e.g., BIMO, EMA GCP inspections).
• Demonstrated understanding of issue management, risk management, and CAPA effectiveness in clinical trial environments.
• Experience with batch review and release for clinical phase products.
• Strong collaboration skills and sufficient technical acumen to enable effective cross-functional partnering with Clinical Operations, Regulatory, Technical Operations, and other key stakeholders.
• Excellent written and verbal communication skills with strong executive presence and influencing capabilities.
• 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.

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.

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