Contract GMP Quality Senior Manager (Biologics & Devices)

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Vertex seeks a GMP Operational Quality Senior Manager to lead QA activities, ensuring compliance across drug products and devices. This role coordinates complex projects, focusing on GMP disposition and quality systems improvements.

The candidate will drive investigations, CAPA and risk management, review batch records, and support audits. A strong background in cGMPs, biopharma manufacturing, and vendor quality is essential.

Qualifications

• In‑depth knowledge of both conceptual and practical cGMPs in biologics + devices pharmaceutical setting.
• Experience managing complex projects with CMOs and continuous improvement within timelines.
• Experience with quality risk management best practices.

Responsibilities

• Collaborate with internal and external partners to resolve complex quality issues to ensure compliant solutions.
• Participate in cross‑functional teams as a seasoned quality technical resource.
• Draft and enforce quality agreements between CMOs/Suppliers and Vertex as needed.
• Assist Change Control owners with ensuring compliance to change procedure requirements.
• Initiate and assess change controls.
• Conduct quality investigations/deviations and review CAPA plans for adequacy and compliance.
• Ensure CAPA actions are identified and addressed.

Skills

Quality management

GxP knowledge

CAPA

Root cause analysis

Risk assessment

Documentation reviews

Education

Bachelor's degree in a scientific or allied health field

Tools

QDocs

Trackwise

Veeva

Job description

Vertex seeks a GMP Operational Quality Senior Manager to lead QA activities, ensuring compliance across drug products and devices. This role coordinates complex projects, focusing on GMP disposition and quality systems improvements.

The candidate will drive investigations, CAPA and risk management, review batch records, and support audits. A strong background in cGMPs, biopharma manufacturing, and vendor quality is essential.