Senior GMP Quality & Compliance Specialist

Vertex Pharmaceuticals; Boston (MA); On-site; USD 90,000 - 96,000; Full time

Job summary

Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Senior Specialist Contractor to provide expert quality assurance and regulatory compliance support for commercial disposition. You will lead quality investigations, CAPA, change control, and risk mitigation across Vertex and supplier sites.

The role emphasizes cross-functional collaboration, document review, and continuous improvement in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 3 years of experience in GMP/quality roles.
• Experience with GMP manufacturing and batch release.
• Knowledge of cGMP requirements governing oral solid dosage forms.

Responsibilities

• Provide quality oversight to manufacturing operations within Vertex or at contracted suppliers.
• Enforce Quality Agreements between CMOs/Suppliers and Vertex.
• Assist Change Control owners with ensuring compliance to change procedure requirements.
• Support change control assessments, implementation, approval, and closure.
• Support quality investigations/deviations and reviews CAPA plans for adequacy and compliance.
• Ensure appropriate CAPA actions are identified and addressed and approve investigations/CAPAs.
• Maintain Quality Metrics to support on time release deliverables.
• Conduct GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports.
• Identify and communicate risks and assist with risk mitigation plans as necessary.
• Identify and facilitate continuous improvement efforts.
• Represent Vertex Quality on cross-functional teams, applying strong communication skills.
• Support continuous improvement projects.

Skills

Quality assurance

cGMP knowledge

CAPA leadership

RCA expertise

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in scientific field

Job description

Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Senior Specialist Contractor to provide expert quality assurance and regulatory compliance support for commercial disposition. You will lead quality investigations, CAPA, change control, and risk mitigation across Vertex and supplier sites.

The role emphasizes cross-functional collaboration, document review, and continuous improvement in a fast-paced biopharma environment.