Senior QA Specialist – GMP Drug Substance & Product

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 90,000 - 96,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks a Senior Specialist to apply QA and regulatory compliance principles across development programs. The role ensures timely delivery of QA activities, supports drug substance and product disposition, and collaborates with CMC Regulatory, GDP Finish Goods, and R&D Quality to drive compliant program progression.

Ideal candidates have working knowledge of GMP from early phase to commercial, strong written and verbal communication, and prior QA

Qualifications

• Bachelor’s degree in a scientific or allied health field
• 3 years of relevant work experience

Responsibilities

• Supports quality oversight for root-cause analysis and product impact assessments for investigations.
• Supports change control assessments, implementation, and closure.
• Identifies and facilitates continuous improvement efforts.
• Drafts and revises Quality Agreements between CMOs/Suppliers and Vertex.
• Represents Vertex Quality on cross-functional teams; supports batch disposition review.
• Performs review of executed batch documentation and release data.
• Supports GMP document review, including certificate of analysis.

Skills

Root Cause Analysis

CAPA

GxP Knowledge

Quality Systems

Cross-functional Collaboration

Change Control

Regulatory Compliance

Investigations

Problem Solving

Communication Skills

Education

Bachelor's degree in science or allied health

Job description

Vertex Pharmaceuticals LLC in Boston, MA seeks a Senior Specialist to apply QA and regulatory compliance principles across development programs. The role ensures timely delivery of QA activities, supports drug substance and product disposition, and collaborates with CMC Regulatory, GDP Finish Goods, and R&D Quality to drive compliant program progression.

Ideal candidates have working knowledge of GMP from early phase to commercial, strong written and verbal communication, and prior QA