Senior GMP QA Lead - Analytical Biologics (Hybrid)

Vertex Pharmaceuticals Inc (US); Boston (MA); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Hybrid-Eligible

On-Site Eligible

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals LLC is seeking a QA/Compliance expert who will ensure alignment with global regulatory requirements and corporate goals. This role manages compliance data review for biologics development and coordinates with Quality Disposition for release testing and CoA approvals.

It requires leading a team and onsite presence in Boston. The position reports to the Director, GMP Operations Quality.

Qualifications

• Master’s degree with 5–8 years of relevant work experience or Bachelor’s with 10+ years in scientific/health field.
• Strong people management experience and ability to lead QA/Compliance teams.
• Broad GMP/GxP knowledge with ability to communicate, collaborate and assess risk.

Responsibilities

• Provide QA oversight for stability programs and data reviews.
• Lead Investigations, deviations (OOS/OOT) and CAPA decisions.
• Coordinate with Quality Disposition and product release activities.
• Approve C of A and stability data; review test article production records.
• Support regulatory/vendor audits and internal process improvements.
• Deliver performance updates to senior QA governance groups.

Skills

GxP Knowledge

Analytical Review

Change Control

Regulatory Compliance

Cross-functional Collaboration

Risk Management

Quality Systems

Data Analysis

Problem Solving

Education

Master’s degree

Bachelor’s degree in science

Tools

Method Validation

Transfer Oversight

Job description

Vertex Pharmaceuticals LLC is seeking a QA/Compliance expert who will ensure alignment with global regulatory requirements and corporate goals. This role manages compliance data review for biologics development and coordinates with Quality Disposition for release testing and CoA approvals.

It requires leading a team and onsite presence in Boston. The position reports to the Director, GMP Operations Quality.