GMP Operational Quality Manager (Pharmaceuticals)

TL;DR

GMP Operational Quality Manager (Pharmaceuticals): Managing on-the-floor quality assurance and cGMP compliance for pharmaceutical batch records and disposition with an accent on root-cause analysis and CAPA. Focus on leading investigations, ensuring regulatory compliance during inspections, and optimizing operational quality processes.

Location: On-Site in Boston, MA (5 days per week)

Salary: $118,400 - $177,600

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Lead on-the-floor QA activities, including batch record review and product disposition in cleanrooms.
• Conduct root-cause analysis and product impact assessments for deviations, OOS, and OOT investigations.
• Manage change control assessments and author SOPs to support commercial quality functions.
• Collaborate with CMOs and suppliers to establish and revise Quality Agreements.
• Represent Quality in cross-functional teams and assist with regulatory agency inspections.
• Train employees on quality processes and drive continuous improvement projects.

Requirements

• Bachelor's degree in a scientific or allied health field.
• 4+ years of experience in pharmaceutical quality assurance.
• Deep understanding of cGMP principles and their application in a pharmaceutical setting.
• Proficiency in leading event investigations, RCA, and CAPA.
• Experience with electronic document systems such as QDoccs, Trackwise, or Veeva.
• Strong communication skills and formal project management experience.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) plan and annual equity awards.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Educational assistance and student loan repayment programs.
• Commuting subsidy and matching charitable donations.