About the Role
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.
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.
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.
- 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.
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.
Recruitment fraud statement
Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:
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- To report job scams, head to ReportFraud.ftc.gov.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.