Associate Director, GMP QA & Global Validation

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking an Associate Director of GMP Operational Quality Assurance to provide expert guidance on quality and regulatory compliance across multiple validation projects for Finished Goods launched globally. The role leads QbD initiatives, CPV measures, and CAPA processes, while aligning with corporate strategies and timelines.

Independent leadership of cross-functional teams, collaboration with external sites, and ongoing process improvements are required to ensure

Qualifications

• Master’s degree in a scientific or allied health field with 5-8 years of relevant experience.

Responsibilities

• Responsible for FG Validation of commercial products in all global regions.
• Standardize Validation processes to ensure compliance and consistency across programs.
• Manage Validation commercialization oversight for operating teams through technical transfer, validation, MBR creation, launch support and process improvements.
• Provide strategic quality oversight to operations at external manufacturing sites in alignment with Vertex Quality strategy.
• Lead or participate in Continuous Improvement initiatives for Validation and product launches.

Skills

GMP Knowledge

QbD Principles

CPV Measures

Root Cause Analysis

Project Management

Cross-functional Leadership

Regulatory Compliance

Quality Assurance

Education

Master’s degree

Bachelor’s degree

Tools

Esko-Artwork

OPM (Oracle)

MS Office

PowerBI

Veeva

Job description

Vertex Pharmaceuticals LLC is seeking an Associate Director of GMP Operational Quality Assurance to provide expert guidance on quality and regulatory compliance across multiple validation projects for Finished Goods launched globally. The role leads QbD initiatives, CPV measures, and CAPA processes, while aligning with corporate strategies and timelines.

Independent leadership of cross-functional teams, collaboration with external sites, and ongoing process improvements are required to ensure