GMP Operational Quality Manager

Responsibilities

• Lead "on the floor" activities including batch record review and product disposition
• Conduct root-cause analysis (RCA) and product impact assessments for deviations, OOS, and OOT investigations
• Identify and implement appropriate CAPA actions
• Perform change control assessments and closure approvals
• Author SOPs to support commercial quality functions
• Collaborate with internal and external partners to resolve quality issues and ensure compliance
• Represent Quality on cross-functional teams and lead continuous improvement projects
• Assist with regulatory agency inspections
• Gown into cleanrooms and controlled environments as required

Requirements

• Bachelor's degree in a scientific or allied health field (or equivalent)
• 4+ years of experience in a pharmaceutical quality environment
• Strong knowledge of cGMP principles and practical application
• Proven experience in Root Cause Analysis (RCA) and CAPA management
• Experience with electronic document management systems such as QDoccs, Trackwise, or Veeva
• Formal project management experience
• Ability to communicate complex technical information effectively to diverse audiences

Benefits

• Competitive salary and annual bonus eligibility
• Annual equity awards
• Comprehensive medical, dental, and vision benefits
• Generous paid time off, including a week-long company shutdown in Summer and Winter
• Educational assistance and student loan repayment programs
• 401(k) with company matching
• Commuting subsidies

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to treating the underlying causes of multiple chronic, life-shortening genetic diseases and continues to advance a robust clinical pipeline across various modalities.