Associate Director - GMP Quality Operations

Socket.dev; Boston (MA); On-site; USD 157,000 - 235,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Educational assistance programs

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality to oversee a QMS team and ensure quality deliverables meet global regulatory requirements. The role emphasizes talent development, process improvement, and strategic alignment with Vertex's objectives.

The incumbent will mentor staff, manage cross-functional collaborations, and lead investigations, CAPAs, and risk assessments while supporting regulatory submissions and inspection readiness.

Qualifications

• In-depth knowledge of cGMPs and global GMP requirements in pharma.
• Proven ability to build and mentor high-performing teams.
• Experience leading quality investigations, CAPAs, and risk assessments.

Responsibilities

• Oversee GMP quality activities and ensure deliverables meet regulatory standards.
• Lead and develop the Quality team, aligning group goals with corporate objectives.
• Coordinate quality agreements with CMOs/vendors and monitor performance.
• Support regulatory inspections and participate in audit readiness.

Skills

cGMP knowledge

Team leadership

Regulatory inspections

Project management

Risk management

Mentoring

Education

Bachelor's degree in science or allied health

Tools

Trackwise

QDocs

Veeva

Job description

Vertex is seeking an Associate Director, GMP Operational Quality to oversee a QMS team and ensure quality deliverables meet global regulatory requirements. The role emphasizes talent development, process improvement, and strategic alignment with Vertex's objectives.

The incumbent will mentor staff, manage cross-functional collaborations, and lead investigations, CAPAs, and risk assessments while supporting regulatory submissions and inspection readiness.