VP, Quality

Treeline Biosciences•Watertown, MA

2h•$285,000 - $350,000

About The Position

The Head of Quality is responsible for providing strategic and operational Quality oversight for manufacturing, clinical operations, pharmacovigilance, and external partner activities across all phases of drug development. This individual will lead the development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support clinical development, inspection readiness, manufacturing scale-up, and future commercialization activities. The Head of Quality will work cross-functionally with CMC, Regulatory, Clinical Operations, Clinical Supply, Technical Operations, and external CMO, CRO, CDMO, and PV partners to ensure compliance with applicable global regulations and to maintain 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.
Minimum of 10+ years of Quality Assurance experience in an FDA-regulated Biotech or Pharmaceutical environment with increasing levels of responsibility.
Demonstrated leadership experience, including direct people management and building high-performing teams in a fast-paced biotech environment.
Experience supporting programs from clinical development through late-stage development and/or commercial readiness.
Strong working knowledge of global GxP requirements, including cGMPs (FDA/ICH), GCP, GCLP, GPV, and applicable international regulations and guidelines.
Experience in batch review and release for clinical phase products.
Experience authoring and reviewing SOPs, deviations, CAPAs, investigations, and change controls.
Experience performing and managing Quality audits and regulatory inspections.
Demonstrated understanding of issue management, risk management, and CAPA effectiveness in clinical and manufacturing environments.
Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and pharmacovigilance vendors.
Strong understanding of GMP requirements for drug development, manufacturing scale-up, and inspection readiness.
Working knowledge of oncology drug development preferred.
Strong ability to partner and collaborate effectively cross-functionally with Clinical Operations, Technical Operations, Regulatory, 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 process improvements.
Demonstrated commitment to quality, compliance, patient safety, and data integrity.

Nice To Haves

Working knowledge of oncology drug development preferred.

Responsibilities

Plan, conduct, and complete reports for CMO, CRO, CDMO, PV vendor, and clinical site audits.
Lead external Health Authority inspections, internal audits, and inspection readiness activities across GCP, GMP, and GPV functions.
Establish, implement, and maintain scalable Quality Management Systems to ensure adherence to applicable global regulatory requirements and industry standards.
Define and drive a pragmatic, phase-appropriate 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.
Oversee batch record review (Executed and Master) for all phases of manufacturing, including drug substance, drug product, packaging, labeling, and associated intermediates.
Responsible for final disposition and release of clinical product, including country-specific release requirements and collaboration with Qualified Persons (QPs).
Provide Quality oversight of external manufacturing, laboratory, packaging, labeling, and distribution partners.
Ensure effective oversight and timely resolution of deviations, investigations, CAPAs, change controls, and product complaints.
Review and approve analytical documentation, including analytical methods, validation protocols and reports, specifications, stability protocols, reports, and expiry extensions.
Provide Quality input into CMC activities, validation strategies, manufacturing scale-up, and commercial readiness initiatives.
Oversee Quality review and approval of IMPD/IND CMC sections and clinical product labels.
Ensure Quality approaches appropriately support execution of clinical trials, including oversight of CROs and GCP compliance activities.
Oversee pharmacovigilance quality activities and vendor oversight to ensure compliance, data integrity, and effective safety surveillance.
Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization.
Keep current with global health authority laws and regulations; identify gaps and implement process improvements resulting from new or revised regulations or guidance.
Author, review, and revise SOPs, policies, and controlled quality documentation.
Implement continuous process improvements to enhance operational efficiency and compliance.
Partner cross-functionally with Clinical Operations, Regulatory, Technical Operations, and executive leadership to support business objectives and embed quality throughout the organization.
Participate in project teams and sub-teams as needed.