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.
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.
- Minimum of 5 years of hands-on experience in one or more of the following partner technical disciplines before transferring into a QA role: Chemical Development/Manufacturing, Drug Product Development/Manufacturing, Analytical Development, Clinical Trial Management.
- Demonstrated success in building and leading a 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, including cGMPs (FDA/ICH), GCP, GCLP, GPV, and applicable international regulations and guidelines.
- Expertise in batch review and release for clinical phase products.
- Expertise authoring and reviewing SOPs, deviations, CAPAs, investigations, and change controls.
- Expertise performing and managing Quality audits and regulatory inspections.
- Demonstrated understanding of issue management, risk management, and CAPA effectiveness in clinical and manufacturing environments.
- Expertise overseeing quality aspects of global vendor networks, including CROs, CMOs, CDMOs, and pharmacovigilance vendors.
- Strong collaboration skills and sufficient technical acumen to enable effective enable cross-functional partnering 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 Quality Systems improvements.
- Demonstrated commitment to quality, compliance, patient safety, and data integrity.
- Working knowledge of oncology drug development preferred.
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:
- Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
- We do not conduct interviews through RingCentral, Skype or Telegram.
- Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
- You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
- 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.