Senior QA Leader, Clinical Analytics & GMP (Hybrid)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 117,000 - 124,000; Full time

Job summary

Vertex Pharmaceuticals LLC seeks a Sr. Quality Manager to provide end-to-end QA oversight of contract analytical labs supporting clinical and commercial programs. You will own vendor oversight, drive investigations, CAPAs, and continuous improvement across cGMP QC environments.

The role requires leading multi-functional teams, enforcing Quality Agreements, and ensuring compliance with Vertex quality standards. Hybrid work arrangement in a fast-paced pharmaceutical setting.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 6 years of experience in analytical quality or equivalent.
• Experience in early Phase to Phase 3 Analytical Quality preferred.

Responsibilities

• Provide end-to-end QA oversight of contract analytical laboratories.
• Lead vendor meetings to enhance oversight of vendor performance.
• Draft and enforce Quality Agreements with CMOs/Suppliers.
• Support change control and assess/capitalize on CAPA actions.
• Conduct GMP document review and coordinate audit activities.
• Lead investigations, RCA, and risk mitigation efforts.

Skills

cGMP knowledge

GMP knowledge

Leadership

Cross-functional teamwork

Communication

QA advisory

RCA

Education

Bachelor's degree in science or allied health

Tools

Veeva

Job description

Vertex Pharmaceuticals LLC seeks a Sr. Quality Manager to provide end-to-end QA oversight of contract analytical labs supporting clinical and commercial programs. You will own vendor oversight, drive investigations, CAPAs, and continuous improvement across cGMP QC environments.

The role requires leading multi-functional teams, enforcing Quality Agreements, and ensuring compliance with Vertex quality standards. Hybrid work arrangement in a fast-paced pharmaceutical setting.