Associate Director, GMP Operational Quality (Biologics and Devices)

Location: Boston, MA, United States. Hybrid work is available up to two days remotely per week, or the role may be performed on-site five days per week.

Base salary: $94,600–$141,800 per year, plus potential annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and improving patient outcomes.

What you will do

• Lead Quality oversight for external drug substance manufacturing and disposition from development through process performance qualification.
• Partner with Manufacturing, Quality Control, MSAT, Regulatory Affairs, CDMOs, suppliers, and Product Quality Leads to resolve complex quality issues.
• Lead deviation investigations, including OOS/OOT events, root cause analysis, CAPA strategy, and effectiveness assessments.
• Review and approve change controls, investigations, CAPAs, master and executed batch records, and Quality Agreements.
• Analyze quality metrics, identify compliance risks, and drive continuous improvement and risk mitigation.
• Support regulatory submissions, partner and agency audits, major development milestones, clinical supply manufacturing, PPQ, and inspections.

Requirements

• Bachelor’s degree in a scientific or allied health field, or an equivalent degree.
• Typically 8+ years of relevant GMP Quality experience, including leadership of complex quality initiatives and QA oversight of external manufacturing operations.
• In-depth knowledge of cGMP principles and global GMP manufacturing requirements in a biologics pharmaceutical setting.
• Experience with contract manufacturing organizations, quality risk management, complex event investigations, root cause analysis, CAPA, and effectiveness assessments.
• Leadership, influencing, communication, independent judgment, and stakeholder management skills in matrixed environments.
• Experience with electronic document management systems such as QDocs, TrackWise, and Veeva.

Culture & Benefits

• Continuous learning and opportunities to adopt advances in AI, technology, automation, and industry practices.
• Medical, dental, and vision benefits with paid time off, including summer and winter company shutdowns.
• Educational assistance programs, including student loan repayment support.
• Commuting subsidy, matching charitable donations, and 401(k) benefits.
• Equal employment opportunity, reasonable accommodations, and an inclusive workplace.