Senior GMP Quality & CAPA Specialist

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 94,000 - 141,000; Full time

Benefits offered by this job

Hybrid work eligibility

On-site work option

Job summary

Vertex Pharmaceuticals Incorporated in Boston seeks a GMP Operational Quality Senior Specialist to support quality assurance and regulatory compliance across investigations, CAPA actions, and change control activities.

The role emphasizes cross-functional collaboration, root cause analysis, and continuous improvement in a fast-paced pharmaceutical environment, with hybrid or on-site scheduling.

Qualifications

• Bachelor's degree in scientific or allied health field (or equivalent degree).
• Typically requires 2 years of experience, or the equivalent combination of education and experience.

Responsibilities

• Oversees RCA and product impact assessments for deviations, OOS, and OOT investigations, ensuring CAPA actions are identified.
• Supports change control assessments, implementation, and closure.
• Facilitates continuous improvement initiatives.
• Supports drafting/revising Quality Agreements with CMOs/Suppliers and Vertex.
• Represents Vertex Quality on cross-functional teams with strong communication.
• Supports continuous improvement projects.

Education

Bachelor's degree in scientific or allied health field

Typically requires 2 years of experience

Job description

Vertex Pharmaceuticals Incorporated in Boston seeks a GMP Operational Quality Senior Specialist to support quality assurance and regulatory compliance across investigations, CAPA actions, and change control activities.

The role emphasizes cross-functional collaboration, root cause analysis, and continuous improvement in a fast-paced pharmaceutical environment, with hybrid or on-site scheduling.