Global Inspection Lead – GCP/GVP QA & Regulatory

Millipore Corporation; Billerica (MA); Hybrid; USD 139,000 - 209,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

EMD Electronics in the United States is seeking an Inspection Management Lead to coordinate GCP/GVP inspections for R&D projects. Hybrid work 3x per week, based in Billerica, MA or Boston, MA with onsite requirements for inspections.

You will host inspections, prepare responses, and drive continuous improvement of inspection readiness and processes within Healthcare R&D worldwide.

Requirements include 8+ years QA experience, Bachelor’s in a scientific field, and travel up to 20%.

Qualifications

• Minimum 8 years QA experience with at least 5 years in Clinical QA.
• Bachelor's degree with a focus on scientific subjects.
• Extensive experience with regulatory inspections (MHRA, FDA, EMA, PMDA).
• GxP areas knowledge (GCP, GLP, GVP).
• Ability to travel up to 20% globally.

Responsibilities

• Coordinate preparation, execution and close-out of GCP/GVP inspections for R&D.
• Host or participate in inspections and support inspection leads.
• Develop and implement proactive inspection readiness strategies.
• Maintain an effective inspection process across Healthcare R&D worldwide.
• Provide regular reports on inspection status and CAPA progress.
• Share knowledge and lessons learned from inspections across teams.

Skills

QA experience

Regulatory inspections

GxP knowledge

Travel

Education

Bachelor's degree in scientific subjects

Job description

EMD Electronics in the United States is seeking an Inspection Management Lead to coordinate GCP/GVP inspections for R&D projects. Hybrid work 3x per week, based in Billerica, MA or Boston, MA with onsite requirements for inspections.

You will host inspections, prepare responses, and drive continuous improvement of inspection readiness and processes within Healthcare R&D worldwide.

Requirements include 8+ years QA experience, Bachelor’s in a scientific field, and travel up to 20%.