Associate Director, GMP Quality & Validation

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 160,000 - 240,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated in Boston seeks an Associate Director of GMP Operational Quality Assurance to lead global validation programs and ensure cGMP compliance across product launches and continuous improvements.

You will partner with internal stakeholders to standardize validation processes, drive CAPA actions, and oversee quality assurance activities across external manufacturing partners in support of FG products worldwide.

Qualifications

• Master's degree with 5-8 years of relevant work experience or Bachelor's with 9+ years relevant background.
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Responsibilities

• Oversee FG Validation for commercial products in all global regions.
• Provide quality guidance for root-cause analysis and CAPA actions.
• Partner with internal stakeholders to establish packaging Validation best practices.
• Establish QbD principles and CPPs for manufacturing processes.
• Lead continuous improvement initiatives in validation and product launch programs.

Skills

GMP knowledge

Quality Assurance

Regulatory compliance

Project management

Cross-functional leadership

Education

Master's degree in scientific field

Bachelor's degree in scientific or allied health field

Tools

Esko-Artwork Management System

OPM (Oracle)

PowerBI

Veeva

Job description

Vertex Pharmaceuticals Incorporated in Boston seeks an Associate Director of GMP Operational Quality Assurance to lead global validation programs and ensure cGMP compliance across product launches and continuous improvements.

You will partner with internal stakeholders to standardize validation processes, drive CAPA actions, and oversee quality assurance activities across external manufacturing partners in support of FG products worldwide.