GMP Operational Quality Manager

Responsibilities

• Lead "on the floor" activities to support 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 to ensure compliant solutions
• Perform change control assessments and manage closure approvals
• Author SOPs to support commercial quality functions and maintain Quality Agreements
• Represent Quality on cross-functional teams and lead continuous improvement projects
• Gown into cleanrooms and controlled environments to support manufacturing operations
• Assist with regulatory agency inspections and collect data for quality metrics

Requirements

• Bachelor's degree in a scientific or allied health field (or equivalent)
• 4+ years of experience in a pharmaceutical quality assurance environment
• Deep understanding of the conceptual and practical application of cGMPs
• Proven expertise in leading event investigations, Root Cause Analysis (RCA), and CAPA
• Experience using electronic document management systems such as QDoccs, Trackwise, or Veeva
• Ability to gown into cleanrooms and work in controlled environments
• Strong communication skills with the ability to influence cross-functional team members

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.