Hybrid GMP Quality Operations Specialist

MFS Investments; Boston (MA); Hybrid; USD 94,000 - 141,000; Full time

Benefits offered by this job

Hybrid-Eligible

Annual bonus

Equity awards

Total Rewards benefits

Job summary

Vertex is seeking a GMP Operational Quality Senior Specialist in Boston to support quality assurance and regulatory compliance across investigations, CAPA, and change control. The role emphasizes root-cause analysis, product impact assessments, and collaboration with cross-functional teams.

The ideal candidate has a Bachelor's degree in a scientific field, 2+ years of relevant experience, and strong communication skills in a fast-paced, cGMP pharmaceutical setting.

Qualifications

• Experience supporting multiple projects within objectives and timelines.
• Experience supporting cross-functional team members and collaborating effectively.
• Strong written and verbal communication skills.
• Able to integrate activities with other groups and project teams.
• Ability to evaluate quality matters and solve straightforward problems using precedent.

Responsibilities

• Supports quality oversight for root-cause analysis and product impact assessment for investigations (deviations, OOS, OOT).
• Supports change control assessments, implementation and closure.
• Identifies and facilitates continuous improvement efforts.
• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex.
• Represents Quality on cross-functional teams with strong communication and collaboration.
• Supports continuous improvement projects.

Skills

Root Cause Analysis

CAPA

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in scientific field

Job description

Vertex is seeking a GMP Operational Quality Senior Specialist in Boston to support quality assurance and regulatory compliance across investigations, CAPA, and change control. The role emphasizes root-cause analysis, product impact assessments, and collaboration with cross-functional teams.

The ideal candidate has a Bachelor's degree in a scientific field, 2+ years of relevant experience, and strong communication skills in a fast-paced, cGMP pharmaceutical setting.