Associate Director, GMP Quality Operations

Biopharma Careers; Boston (MA); On-site; USD 157,000 - 235,000; Full time

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality for on-site work at our Leiden Center in Boston. You will oversee QA teams, drive QMS initiatives, and ensure GCP/GMP compliance across clinical and commercial programs.

The role emphasizes leadership, risk management, and collaboration with CROs and vendors. Expect to mentor staff, manage audits, and contribute to continuous quality improvements while aligning with corporate regulatory requirements.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• 8 years of work experience and 2 years of management experience typically required.
• Extensive knowledge of cGMPs and GMP regulations.
• Experience leading investigations, RCA, and CAPA.

Responsibilities

• Leads QA Operations for GMP manufacturing and testing activities.
• Manages QA On The Floor and QA Walkthrough programs.
• Acts as QA lead for clinical programs ensuring GCP compliance.
• Develops risk-based audit plans and oversees audits.
• Oversees domestic and international audits for clinical investigators.

Skills

cGMP knowledge

GMP requirements

Team management

Project management

Cross-functional leadership

RCA & CAPA

GCP compliance

Electronic document management

Education

Bachelor's degree in science

Tools

QDoccs

Trackwise

Veeva

Job description

Vertex is seeking an Associate Director, GMP Operational Quality for on-site work at our Leiden Center in Boston. You will oversee QA teams, drive QMS initiatives, and ensure GCP/GMP compliance across clinical and commercial programs.

The role emphasizes leadership, risk management, and collaboration with CROs and vendors. Expect to mentor staff, manage audits, and contribute to continuous quality improvements while aligning with corporate regulatory requirements.