Treeline Biosciences
Vice President, Head of Quality Assurance
Watertown, Massachusetts, United States · Exec
Sponsorship not specified$285k-$350kDetected 11 days ago
GCPProduct ManagementSupply ChainHRClinical TrialsGMPFDA RegulatoryPharmacovigilanceCommunicationCollaborationProblem SolvingGxP
> stay_score
odds of building a lasting career here
37Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
No strong sponsorship signal in the public record yet. In the full product we resolve the exact legal entity and show its filing history with a confidence score — treat as unverified until then.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
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.
- 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.
- Define and drive a pragmatic, data-driven, phase-appropriate Quality strategy aligned with company objectives and development milestones.
- Provide Quality oversight of external manufacturing, laboratory, packaging, labeling, and distribution partners
- Ensure Quality approaches appropriately support execution of clinical trials, including oversight of CROs and GCP compliance activities.
- Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization.
- Minimum of 5 years of hands-on experience in one or more of the following partner technical disciplines before transferring into a
- Demonstrated success in building and leading a quality organization capable of supporting a clinical/early commercial small pharmaceutical company
- 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.
Requirements
- Minimum of 10+ years of Quality Assurance experience in an FDA-regulated Biotech or Pharmaceutical environment with increasing levels of responsibility.
- 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.
- Expertise overseeing quality aspects of global vendor networks, including CROs, CMOs, CDMOs, and pharmacovigilance vendors.
- You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
Nice to have
- BA/BS in Science, Engineering, or related discipline required
- advanced degree (MS, PhD, PharmD, or equivalent) preferred.
- Working knowledge of oncology drug development preferred.
Compensation
- 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.
Benefits
- Lead external Health Authority inspections, internal audits, and inspection readiness activities across GCP, GMP, and GPV functions.
- Keep current with global health authority laws and regulations; identify gaps and implement process improvements resulting from new or revised regulations or guidance.
Company info
- Keep the following in mind to protect yourself: - Treeline Biosciences will never ask for money from you as part of our recruitment process.
Apply directly at Treeline Biosciences →Create a free account for alerts like thisView Treeline Biosciences immigration profile
This listing is sourced directly from Treeline Biosciences's careers page and normalized into a canonical job model.