VP of Quality Assurance & Compliance (GxP)

Treeline Biosciences, Inc.; Watertown (MA); Presencial; USD 285.000 - 350.000; Jornada completa

Descripción de la vacante

Treeline Biosciences, Inc. in Watertown, MA is seeking a Vice President, Head of Quality Assurance to lead global quality programs across manufacturing, labs, and clinical operations.

This executive will shape strategy, implement scalable QA systems, and ensure readiness for regulatory submissions and inspections. The role demands 15+ years in FDA-regulated environments, strong leadership, and deep GxP expertise, with a proven track record building high-performing QA teams and partnering across

Formación

• BA/BS in Science, Engineering, or related discipline required.
• 15+ years of QA experience in FDA-regulated biotech or pharmaceutical environments with increasing responsibility.
• 5+ years leading technical QA disciplines prior to QA leadership.
• Proven record building and leading a QA organization for clinical-stage programs.
• Experience with NDA/MAA submissions and pre-approval inspections is a plus.
• Mastery of global GxP requirements and international guidelines.
• Strong collaboration with CMC, Regulatory, Clinical Operations, and external partners.

Responsabilidades

• Set quality strategy and priorities aligned with company objectives and milestones.
• Build and lead a scalable QA organization across manufacturing, labs, and clinical activities.
• Own and evolve the Quality Management System with global GxP adherence.
• Drive data-driven quality strategy, governance, and metrics for risk management.
• Oversee CDMOs, contract labs, audits, and supplier qualification.
• Plan and conduct audits of manufacturing, lab, distribution, and clinical vendors.
• Lead external Health Authority inspections and inspection readiness.
• Review analytical documentation and release of clinical materials.
• Provide QA input into CMC activities including tech transfer and scale-up.
• Manage deviations, investigations, CAPAs, change controls, and complaints.
• Ensure GDP, pharmacovigilance quality activities and GCP compliance.
• Collaborate with stakeholders to ensure data integrity and system validation.

Conocimientos

Quality leadership

GxP compliance

Audit & inspections

Cross-functional collaboration

Regulatory strategy

Executive presence

Educación

BA/BS in Science, Engineering, or related discipline

MS/PhD/ PharmD or equivalent preferred

Descripción del empleo

Treeline Biosciences, Inc. in Watertown, MA is seeking a Vice President, Head of Quality Assurance to lead global quality programs across manufacturing, labs, and clinical operations.

This executive will shape strategy, implement scalable QA systems, and ensure readiness for regulatory submissions and inspections. The role demands 15+ years in FDA-regulated environments, strong leadership, and deep GxP expertise, with a proven track record building high-performing QA teams and partnering across