GMP Operational Quality Manager (Pharmaceuticals)

TL;DR

GMP Operational Quality Manager (Pharmaceuticals): Providing quality oversight and compliance for analytical testing at contracted suppliers with an accent on GMP requirements and regulatory compliance. Focus on leading complex quality investigations, managing CAPAs, and ensuring alignment with corporate goals.

Location: Must be based in Boston, MA (Hybrid or On-Site)

Company

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

What you will do

• Provide quality oversight and support for analytical testing at contracted suppliers.
• Draft and enforce Quality Agreements between CMOs/Suppliers and the company.
• Manage change controls, conduct quality investigations, and review corrective action plans.
• Lead continuous improvement efforts and maintain quality metrics.
• Review GMP documents including procedures, specifications, and protocols.
• Coordinate internal and external audit programs and prepare audit responses.

Requirements

• Location: Must be based in Boston, MA
• Bachelor’s degree in a scientific or allied health field.
• 5+ years of relevant work experience in a pharmaceutical setting.
• In-depth knowledge of global cGMP requirements for oral drug products.
• Experience with drug substance and drug product manufacturing (oral solid dosage forms preferred).
• Strong experience in Root Cause Analysis (RCA) and CAPA management.

Nice to have

• Experience with electronic document management systems such as Veeva.

Culture & Benefits

• Market-leading medical, dental, and vision benefits.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• 401(k) plan and commuting subsidy.
• Educational assistance programs and student loan repayment.
• Flexible work arrangement options (Hybrid-eligible).