Associate Director, GMP Operational Quality
Vertex Pharmaceuticals
August 12, 2026
Remote friendly (Boston, MA)
United States
Operations
Responsibilities:
- Lead a Quality Operations team supporting GMP manufacturing and testing (including disposition of intermediates, working cell banks, and clinical/commercial drug products).
- Manage QA On The Floor and QA Walkthrough programs for 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 ensure data integrity.
- Maintain knowledge of GCP standards, trends, and methodologies.
- Liaise with internal clinical functions and external partners (CROs, vendors, investigator sites) to ensure quality and consistency.
- Provide QA protocol review; participate in Operational Review Boards to identify risks and develop mitigation strategies.
- Develop and execute risk-based audit plans; review audit reports and evaluate responses and CAPA plans.
- Lead domestic/international audits for clinical investigators (ICH GCP, applicable regulations, company standards).
- Lead quality issue investigations, RCA, and CAPA development; support corrective/preventive action implementation.
- Contribute to continuous quality improvement and proactive inspection readiness.
- Support regulatory agency inspections at Vertex and/or investigator sites.
- May serve as GCP Quality Management System representative; participate in impacted SOP/WI review.
- Review KPI data and trends; analyze risk and propose CAPA/remedial actions.
- Build/maintain QA-to-QA relationships with GCP vendors and participate in vendor committees.
- Assist with budgeting/scheduling.
- People management: recruiting/onboarding, performance management, engagement/retention, succession planning, coaching/training and IDPs; oversee day-to-day team operations and assist workforce planning/resource forecasting.
Qualifications & Skills:
- In-depth cGMP and global GMP knowledge; experience managing quality for GMP manufacturing.
- Proven ability to build high-performing teams and develop talent.
- Strong leadership and communication; ability to influence cross-functionally.
- Experience managing complex projects/teams using project management tools.
- Ability to independently lead cross-functional teams for Quality.
- Expertise in mentoring/technical knowledge transfer.
- Risk-based decision-making; substantial experience with investigations, RCA, and CAPA.
- Exposure to regulatory inspections across GxPs.
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
Education & Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- Typically 8 years of work experience and 2 years of management experience (or equivalent).
Application instructions:
- Contact the recruiter or hiring manager or Talent Acquisition at ApplicationAssistance@vrtx.com for accommodation requests related to the hiring process/performance of essential functions.
- Lead a Quality Operations team supporting GMP manufacturing and testing (including disposition of intermediates, working cell banks, and clinical/commercial drug products).
- Manage QA On The Floor and QA Walkthrough programs for 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 ensure data integrity.
- Maintain knowledge of GCP standards, trends, and methodologies.
- Liaise with internal clinical functions and external partners (CROs, vendors, investigator sites) to ensure quality and consistency.
- Provide QA protocol review; participate in Operational Review Boards to identify risks and develop mitigation strategies.
- Develop and execute risk-based audit plans; review audit reports and evaluate responses and CAPA plans.
- Lead domestic/international audits for clinical investigators (ICH GCP, applicable regulations, company standards).
- Lead quality issue investigations, RCA, and CAPA development; support corrective/preventive action implementation.
- Contribute to continuous quality improvement and proactive inspection readiness.
- Support regulatory agency inspections at Vertex and/or investigator sites.
- May serve as GCP Quality Management System representative; participate in impacted SOP/WI review.
- Review KPI data and trends; analyze risk and propose CAPA/remedial actions.
- Build/maintain QA-to-QA relationships with GCP vendors and participate in vendor committees.
- Assist with budgeting/scheduling.
- People management: recruiting/onboarding, performance management, engagement/retention, succession planning, coaching/training and IDPs; oversee day-to-day team operations and assist workforce planning/resource forecasting.
Qualifications & Skills:
- In-depth cGMP and global GMP knowledge; experience managing quality for GMP manufacturing.
- Proven ability to build high-performing teams and develop talent.
- Strong leadership and communication; ability to influence cross-functionally.
- Experience managing complex projects/teams using project management tools.
- Ability to independently lead cross-functional teams for Quality.
- Expertise in mentoring/technical knowledge transfer.
- Risk-based decision-making; substantial experience with investigations, RCA, and CAPA.
- Exposure to regulatory inspections across GxPs.
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
Education & Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- Typically 8 years of work experience and 2 years of management experience (or equivalent).
Application instructions:
- Contact the recruiter or hiring manager or Talent Acquisition at ApplicationAssistance@vrtx.com for accommodation requests related to the hiring process/performance of essential functions.