Associate Director, GMP Operational Quality
Vertex Pharmaceuticals
June 30, 2026
On-site
Boston, MA
Operations
Associate Director, GMP Operational Quality
Key Duties and Responsibilities:
- Lead a Quality Operations team supporting GMP manufacturing/testing, including disposition of intermediates, working cell banks, and clinical/commercial drug products.
- Manage QA On the Floor and QA Walkthrough programs supporting Vertex GMP facilities.
- Serve as Quality Lead for assigned clinical programs; provide GCP compliance interpretation, consultation, and support to protect subject safety/rights/well-being and data integrity.
- Maintain knowledge of current GCP trends, standards, and methodologies.
- Liaise with internal clinical functions and external parties (CROs, vendors, investigator sites) to ensure quality and consistency.
- Provide QA protocol review; participate in Operational Review Boards to identify operational risks and develop risk mitigation.
- Develop risk-based audit plans; ensure audits occur per plan; review reports; evaluate responses and CAPA.
- Lead/ manage domestic and international audits for clinical investigators to ensure ICH GCP, regulations, and company standards compliance.
- Lead quality issue investigations, root cause analysis, and CAPA; support implementation for sustainable compliance.
- Support continuous quality improvement, inspection readiness, and regulatory/agency inspection support.
- May serve as GCP Quality Management System representative; review impacted SOP/WI.
- Review PI data/trends; analyze risk and propose remedial/corrective/preventive actions; support process improvement.
- Manage QA-to-QA relationships with GCP vendors; support vendor joint operating committees as needed.
- Assist management with budgeting and scheduling.
- People management: recruiting/onboarding, performance management, engagement/retention, succession planning, coaching/training and IDPs.
- Provide oversight of day-to-day team operations; assist workforce planning/resource modeling and forecasting.
Knowledge/Skills:
- In-depth cGMP knowledge and global GMP requirements for GMP manufacturing quality.
- Track record building high-performing teams and developing individuals.
- Strong management and project management skills; lead cross-functional teams and represent Quality unit.
- Mentoring and technical knowledge transfer.
- Cross-functional communication and influence.
- Risk-based decision-making; lead event investigations, RCA, and CAPA.
- Extensive regulatory inspection experience across applicable GxPs.
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
Education/Experience:
- Bachelor’s degree in scientific/allied health field (or equivalent).
- Typically 8 years’ work experience and 2 years’ management experience (or equivalent).
Pay Range: $156,600 - $234,800
Benefits (if applicable): Eligible for annual bonus and annual equity awards; may be eligible for overtime pay.
On-site location/shift: Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA 02210. 1st shift B1: Wed–Sat 7:00am–5:30pm.
Key Duties and Responsibilities:
- Lead a Quality Operations team supporting GMP manufacturing/testing, including disposition of intermediates, working cell banks, and clinical/commercial drug products.
- Manage QA On the Floor and QA Walkthrough programs supporting Vertex GMP facilities.
- Serve as Quality Lead for assigned clinical programs; provide GCP compliance interpretation, consultation, and support to protect subject safety/rights/well-being and data integrity.
- Maintain knowledge of current GCP trends, standards, and methodologies.
- Liaise with internal clinical functions and external parties (CROs, vendors, investigator sites) to ensure quality and consistency.
- Provide QA protocol review; participate in Operational Review Boards to identify operational risks and develop risk mitigation.
- Develop risk-based audit plans; ensure audits occur per plan; review reports; evaluate responses and CAPA.
- Lead/ manage domestic and international audits for clinical investigators to ensure ICH GCP, regulations, and company standards compliance.
- Lead quality issue investigations, root cause analysis, and CAPA; support implementation for sustainable compliance.
- Support continuous quality improvement, inspection readiness, and regulatory/agency inspection support.
- May serve as GCP Quality Management System representative; review impacted SOP/WI.
- Review PI data/trends; analyze risk and propose remedial/corrective/preventive actions; support process improvement.
- Manage QA-to-QA relationships with GCP vendors; support vendor joint operating committees as needed.
- Assist management with budgeting and scheduling.
- People management: recruiting/onboarding, performance management, engagement/retention, succession planning, coaching/training and IDPs.
- Provide oversight of day-to-day team operations; assist workforce planning/resource modeling and forecasting.
Knowledge/Skills:
- In-depth cGMP knowledge and global GMP requirements for GMP manufacturing quality.
- Track record building high-performing teams and developing individuals.
- Strong management and project management skills; lead cross-functional teams and represent Quality unit.
- Mentoring and technical knowledge transfer.
- Cross-functional communication and influence.
- Risk-based decision-making; lead event investigations, RCA, and CAPA.
- Extensive regulatory inspection experience across applicable GxPs.
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
Education/Experience:
- Bachelor’s degree in scientific/allied health field (or equivalent).
- Typically 8 years’ work experience and 2 years’ management experience (or equivalent).
Pay Range: $156,600 - $234,800
Benefits (if applicable): Eligible for annual bonus and annual equity awards; may be eligible for overtime pay.
On-site location/shift: Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA 02210. 1st shift B1: Wed–Sat 7:00am–5:30pm.