GMP Quality Operations Leader — Associate Director

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

Benefits offered by this job

Hybrid work model

401(k) and matching contributions

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality to lead a high-performing Quality Operations team focused on GMP manufacturing and testing activities. The role emphasizes risk-based decision making, regulatory compliance, and proactive inspection readiness across programs.

The successful candidate will mentor staff, manage cross-functional relationships with CROs and vendors, and drive continuous quality improvements while aligning with corporate goals and total rewards.

Qualifications

• Bachelor's degree in a scientific or allied health field (or equivalent degree).
• Typically requires 8 years of work experience and 2 years of management experience or the equivalent combination of education and experience.

Responsibilities

• Leads a team in the Quality Operations organization for GMP manufacturing and testing activities.
• Manages QA On The Floor and QA Walkthrough programs.
• Leads quality issue investigations, root cause analysis, and CAPA development.
• Mentors team members and supports workforce planning and resource modeling.

Skills

cGMP knowledge

Quality leadership

GCP compliance

Education

Bachelor's degree in a scientific or allied health field

Tools

QDoccs/Trackwise/Veeva

Job description

Vertex is seeking an Associate Director, GMP Operational Quality to lead a high-performing Quality Operations team focused on GMP manufacturing and testing activities. The role emphasizes risk-based decision making, regulatory compliance, and proactive inspection readiness across programs.

The successful candidate will mentor staff, manage cross-functional relationships with CROs and vendors, and drive continuous quality improvements while aligning with corporate goals and total rewards.