GMP Operational Quality Lead - On-Site Associate Director

Vertex Pharmaceuticals Inc (US); Leiden; On-site; EUR 136,000 - 204,000; Full time

Job summary

Vertex Pharmaceuticals Inc seeks an Associate Director, GMP Operational Quality to lead a Quality Operations team, ensuring GMP compliance and timely delivery of quality deliverables at the Leiden site.

This on-site role emphasizes development of personnel, risk-based audits, CAPA, and collaboration with clinical and external partners; the 1st shift is four 10-hour shifts with start times flexible.

Qualifications

• In-depth knowledge of cGMPs in a pharmaceutical setting and global GMP requirements.
• Experience leading QA on the floor and walkthroughs in GMP facilities.
• Skilled in risk-based decision making and regulatory interpretation.

Responsibilities

• Lead a Quality Operations team supporting GMP manufacturing and testing.
• Manage QA On The Floor and QA Walkthrough programs.
• Provide GCP interpretation and support for clinical programs.
• Develop risk-based audit plans and CAPA activities.
• Coordinate domestic and international audits for Clinical Investigators.

Skills

GMP Quality

Leadership

Regulatory knowledge

GCP/GxP knowledge

Risk-based thinking

Investigation & CAPA

Audit management

Cross-functional collaboration

Education

Bachelor's degree in a scientific or allied health field

Tools

QDoccs

TrackWise

Veeva

Job description

Vertex Pharmaceuticals Inc seeks an Associate Director, GMP Operational Quality to lead a Quality Operations team, ensuring GMP compliance and timely delivery of quality deliverables at the Leiden site.

This on-site role emphasizes development of personnel, risk-based audits, CAPA, and collaboration with clinical and external partners; the 1st shift is four 10-hour shifts with start times flexible.