GMP Quality Senior Specialist: Release & Compliance Lead

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 83,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Senior Quality Specialist (1st Shift) for on-site work in Boston to lead QA activities in support of clinical and commercial Drug Product manufacturing. You will review batch records, approve CoAs, and ensure proper disposition and labeling while archiving essential documents in eDMS.

The role emphasizes collaboration, audit readiness, and continuous improvement. The position requires leadership of cross-functional teams, strong GMP knowledge, and

Qualifications

• Demonstrated success by independently leading cross-functional teams.
• Experience providing QA support and oversight of GMP manufacturing operation including equipment/facilities qualification, utilities and batch release.
• Experience leading investigations, root cause analysis and CAPA; familiarity with Oracle, Veeva.

Responsibilities

• Review batch data and related quality records (deviations, in-process data, EM data, QC release testing).
• Approve CoAs, generate BSE/TSE statements and label products.
• Archive batch records and documents in electronic document management system (eDMS).
• Provide QA support for product release, investigations, CAPAs and disposition decisions including shipment.
• Review and approve Manufacturing documents; release of raw materials and equipment.
• Assist with equipment/ facilities qualification activities and change control; support site programs.
• Support audit readiness, QA walkthroughs, and contribute to process improvements and risk assessments.
• Act as compliance advisor to site business owners to resolve quality issues timely.

Job description

Vertex Pharmaceuticals LLC is seeking a Senior Quality Specialist (1st Shift) for on-site work in Boston to lead QA activities in support of clinical and commercial Drug Product manufacturing. You will review batch records, approve CoAs, and ensure proper disposition and labeling while archiving essential documents in eDMS.

The role emphasizes collaboration, audit readiness, and continuous improvement. The position requires leadership of cross-functional teams, strong GMP knowledge, and