Associate Director, GMP Quality & Compliance

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

Benefits offered by this job

Annual bonus

Equity awards

Medical, dental, vision

Job summary

Vertex Pharmaceuticals Inc. in Boston is seeking an Associate Director, GMP Operational Quality to oversee quality assurance activities, develop personnel, and ensure deliverables meet cGMP and regulatory requirements.

You will lead a Quality team, collaborate with partners, manage audits, CAPA, change controls, and support regulatory submissions while mentoring staff. Hybrid work options with on-site presence in Boston; total rewards include bonus and equity; 8+ years in pharma quality and 2+

Qualifications

• Bachelor's degree in a scientific or allied health field; typically 8+ years of work experience and 2 years of management experience.
• In-depth knowledge of global cGMP requirements and pharmaceutical quality systems.
• Demonstrated ability to manage complex projects/teams and mentor staff.

Responsibilities

• Lead a Quality team providing quality oversight and support to Vertex's business activities.
• Oversee QA responsibilities for Change Controls, GMP investigations and CAPAs.
• Prepare for inspections and support regulatory submissions as applicable.
• Partner with internal/external teams to resolve complex quality issues and drive improvements.

Skills

QA leadership

cGMP knowledge

project management

cross-functional collaboration

audits & inspections

CAPA/RCA

Change Controls

QDocs/Trackwise/Veeva

Education

Bachelor's degree in science

Tools

QDocs

Trackwise

Veeva

Job description

Vertex Pharmaceuticals Inc. in Boston is seeking an Associate Director, GMP Operational Quality to oversee quality assurance activities, develop personnel, and ensure deliverables meet cGMP and regulatory requirements.

You will lead a Quality team, collaborate with partners, manage audits, CAPA, change controls, and support regulatory submissions while mentoring staff. Hybrid work options with on-site presence in Boston; total rewards include bonus and equity; 8+ years in pharma quality and 2+