Senior Quality Manager - cGMP Oversight (Hybrid)

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

Job summary

Vertex Pharmaceuticals LLC in Boston seeks a Sr. Quality Manager to provide end-to-end QA oversight of contract analytical labs supporting clinical and commercial biologics programs. The role involves vendor oversight, investigations, CAPA, and quality systems, with a hybrid work arrangement.

You will lead cross-functional teams, draft Quality Agreements, participate in audits, and drive continuous improvement while ensuring compliance with cGMPs.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 6 years of experience in analytical quality.
• Experience in early Phase to Phase 3 Analytical Quality preferred.
• In-depth knowledge of cGMPs and global GMP requirements.

Responsibilities

• Provide end-to-end QA oversight of contract laboratories supporting clinical and commercial programs.
• Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex.
• Assist Change Control owners with ensuring compliance to change procedures.
• Assess and approve change controls and CAPAs.
• Conduct quality investigations/deviations and root cause analyses.
• Maintain Quality Metrics and drive continuous improvement.
• Support internal and external audits and coordinate audit CAPAs.
• Provide QA advice for partner and regulatory agency audits.

Skills

QA oversight

Cross-functional leadership

Change control

Investigations

Root cause analysis

CAPA

GMP knowledge

Audits

Education

Bachelor's degree

Tools

Veeva

Job description

Vertex Pharmaceuticals LLC in Boston seeks a Sr. Quality Manager to provide end-to-end QA oversight of contract analytical labs supporting clinical and commercial biologics programs. The role involves vendor oversight, investigations, CAPA, and quality systems, with a hybrid work arrangement.

You will lead cross-functional teams, draft Quality Agreements, participate in audits, and drive continuous improvement while ensuring compliance with cGMPs.