VP, Quality Assurance & Regulatory Strategy

Treeline; Watertown (MA); On-site; USD 285,000 - 350,000; Full time

Job summary

Treeline Biosciences in Watertown, MA seeks a Vice President, Head of Quality Assurance to lead GxP quality across manufacturing, labs, and clinical operations from development through approval. You will develop scalable Quality systems, governance, and inspection readiness to support programs toward registration.

You will collaborate with CMC, Regulatory, Clinical, and external partners to ensure data integrity and patient safety, while driving risk-based QA strategy and supplier oversight.

Qualifications

• 15+ years of Quality Assurance experience in an FDA-regulated biotech or pharmaceutical environment with increasing responsibility, including leadership of a quality function.
• 5+ years hands-on experience in Chemical Development/Manufacturing, Drug Product Development/Manufacturing, or Analytical Development.
• Experience supporting programs through clinical development; NDA/MAA submissions and pre-approval inspections a plus.
• Mastery of global GxP requirements and applicable international regulations and guidelines.
• Deep expertise in batch review and disposition for clinical-phase products.
• Experience authoring and reviewing SOPs, deviations, investigations, CAPAs, and change controls; OOS/OOT management.

Responsibilities

• Serve as the executive owner of quality, setting strategy and priorities for Treeline.
• Build and lead a QA organization to support global manufacturing, lab, and clinical activities.
• Own and evolve the Quality Management System in a scalable, phase-appropriate way.
• Define a data-driven Quality strategy with governance frameworks and metrics.
• Provide QA oversight of CDMOs, contract labs, supplier qualification, and audits.
• Plan, oversee, and complete audits of manufacturing, lab, and distribution partners.
• Lead external regulatory inspections and inspection readiness activities.
• Review and approve analytical documentation, methods, validation protocols, and reports.

Skills

Quality Assurance

Regulatory compliance

Leadership

Quality systems

GxP

Audits

Risk management

Vendor management

Data integrity

Cross-functional collaboration

Education

BA/BS in Science, Engineering, or related discipline

MS/PhD/PharmD or equivalent preferred

Job description

Treeline Biosciences in Watertown, MA seeks a Vice President, Head of Quality Assurance to lead GxP quality across manufacturing, labs, and clinical operations from development through approval. You will develop scalable Quality systems, governance, and inspection readiness to support programs toward registration.

You will collaborate with CMC, Regulatory, Clinical, and external partners to ensure data integrity and patient safety, while driving risk-based QA strategy and supplier oversight.