GMP Quality Operations Senior Specialist (Hybrid)

Vertex Pharmaceuticals LLC; Boston (MA); Hybride; USD 94 000 - 141 000; Plein temps

Résumé du poste

Vertex Pharmaceuticals LLC is seeking a GMP Operational Quality Senior Specialist in Boston, MA. The role emphasizes quality assurance, regulatory compliance, and cross-functional collaboration to support investigations and CAPA actions.

You will contribute to change controls, continuous improvement, and drafting Quality Agreements with CMOs/Suppliers, while representing Vertex Quality in cross-functional teams.

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.

Responsabilités

• Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Supports change control assessments, implementation and closure
• Identifies and facilitates continuous improvement efforts
• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects

Connaissances

Project coordination

Cross-functional collaboration

Communication

Team integration

Quality matter evaluation

Fast-paced adaptability

cGMP knowledge

Investigation leadership

Formation

Bachelor's degree in scientific/health field

Description du poste

Vertex Pharmaceuticals LLC is seeking a GMP Operational Quality Senior Specialist in Boston, MA. The role emphasizes quality assurance, regulatory compliance, and cross-functional collaboration to support investigations and CAPA actions.

You will contribute to change controls, continuous improvement, and drafting Quality Agreements with CMOs/Suppliers, while representing Vertex Quality in cross-functional teams.