Product Complaint Quality Lead

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 69,000 - 76,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Product Complaint Manager to support the Product Complaint Quality System within the Small Molecule, Biologics, Device CMC Compliance team. You will partner with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, and QA to drive compliant product complaint processes.

Responsibilities include triage, investigation reports, deviations review, CAPA, plus training cross-functional teams and monitoring

Qualifications

• Experience in a Quality Assurance role supporting complaint management and CAPA.
• Familiarity with device, biologics or small molecule contexts.
• Understanding of GMP/GDP regulatory expectations.

Responsibilities

• Support product complaint processes including reconciliation, triage and SOP management.
• Process incoming clinical and commercial product complaints and initial evaluation.
• Investigate product complaints and author investigation reports; coordinate external investigations as needed.
• Perform quality review of investigations owned by others and escalate critical issues.
• Assist with trending, metrics, and quarterly reporting; participate in cross-functional reviews.
• Provide training on the product complaint process to cross-functional teams.

Skills

Quality Assurance

Complaint management

Root cause investigations

CAPA development

GxP knowledge

GMP/GDP regulations

Technical writing

Communication skills

Cross-functional collaboration

Project management

Education

Master’s degree in a scientific field

Bachelor’s degree in a scientific field

Job description

Vertex Pharmaceuticals LLC is seeking a Product Complaint Manager to support the Product Complaint Quality System within the Small Molecule, Biologics, Device CMC Compliance team. You will partner with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, and QA to drive compliant product complaint processes.

Responsibilities include triage, investigation reports, deviations review, CAPA, plus training cross-functional teams and monitoring