Associate Director, GMP Quality & Operations

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking an Associate Director, GMP Operational Quality to oversee a Quality team, ensure compliant GMP activities, and mentor staff in a fast-paced environment. You will coordinate with internal and external partners, manage QA for change controls, investigations, and CAPAs, and support regulatory inspections to drive continuous improvement across the department.

The role requires strong cGMP knowledge, senior-level project management, and demonstrated

Qualifications

• In-depth knowledge of cGMPs in a pharmaceutical setting.
• Experience leading quality teams and mentoring staff.
• Experience with regulatory inspections and audits.
• Strong risk-based decision making and CAPA handling.

Responsibilities

• Lead a Quality team providing oversight and support to Vertex activities.
• Collaborate with internal and external partners to resolve complex quality issues.
• Oversee vendor performance and Quality Agreements.
• Develop compliant quality processes to support GMP activities.
• Oversee QA support of Change Controls, GMP investigations and CAPAs.
• Track performance metrics and report to senior management.
• Participate in inspection readiness and regulatory site inspections.
• Assist with regulatory submissions review.
• Lead continuous improvements of department processes.

Skills

Quality leadership

Team mentoring

Risk-based decision making

Project management

Cross-functional collaboration

Regulatory compliance

cGMPs knowledge

Audit readiness

Vendor management

Education

Bachelor's degree in a scientific or allied health field

8+ years of work experience and 2 years of management experience

Tools

QDocs

Trackwise

Veeva

Job description

Vertex Pharmaceuticals Incorporated is seeking an Associate Director, GMP Operational Quality to oversee a Quality team, ensure compliant GMP activities, and mentor staff in a fast-paced environment. You will coordinate with internal and external partners, manage QA for change controls, investigations, and CAPAs, and support regulatory inspections to drive continuous improvement across the department.

The role requires strong cGMP knowledge, senior-level project management, and demonstrated