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Job description
About The Role
The Head of Quality Assurance is responsible for providing strategic and operational quality assurance oversight for manufacturing, clinical operations, pharmacovigilance, 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, manufacturing scale-up, commercialization activities, and commercial product lifecycle management. The Head of Quality will work cross-functionally with the CMC, Regulatory, Clinical Operations, and Supply Chain functions as well as 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.
About The Role
The Head of Quality Assurance is responsible for providing strategic and operational quality assurance oversight for manufacturing, clinical operations, pharmacovigilance, 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, manufacturing scale-up, commercialization activities, and commercial product lifecycle management. The Head of Quality will work cross-functionally with the CMC, Regulatory, Clinical Operations, and Supply Chain functions as well as 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.
Responsibilities
Build, lead, and manage a quality assurance team capable of supporting Treeline’s growing global clinical and manufacturing activities throughout the development continuum, including commercialization and lifecycle management.
Provide strategic and operational oversight of Treeline’s Quality Assurance operation
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.
Continue to develop, and maintain Treeline’s Quality Management Systems, in a phase-appropriate manner, to ensure adherence to applicable global regulatory requirements and industry standards.
Author, review, and revise SOPs, policies, and controlled quality documentation.
Define and drive a pragmatic, data-driven, 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.
Provide Quality oversight of external manufacturing, laboratory, packaging, labeling, and distribution partners
Oversee batch record review (Executed and Master) for all phases of manufacturing, including drug substance, drug product, packaging, labeling, and associated intermediates.
Review and approve analytical documentation, including analytical methods, validation protocols and reports, specifications, stability protocols, reports, and expiry extensions.
Review and approve clinical product labels.
Provide Quality input into CMC activities, validation strategies, manufacturing scale-up, and commercial readiness initiatives.
Responsible for final release or other disposition of clinical trial material, including country-specific release requirements and collaboration with Qualified Persons (QPs).
Ensure effective oversight and timely resolution of deviations, investigations, CAPAs, change controls, and product complaints, seeking input from relevant departments to ensure fully informed evaluations of on Quality impact are made.
Review and approve quality aspects of IMPD/IND CMC sections
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.
Participate in project teams and sub-teams as needed.
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Worksite address
watertown, MA, 02472, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.