Sterilization Quality Program Manager

West Pharmaceutical Services, Inc; Exton (PA); On-site; USD 110,000 - 140,000; Full time

Job summary

West Pharmaceutical Services, Inc. in Exton, PA is seeking a Quality Project Manager – Sterilization to lead sterilization quality initiatives across multiple sites, focusing on EtO, steam, and gamma processes within FDA and ISO 13485 frameworks.

The role drives standardization, validation programs, and QMS improvements while ensuring regulatory compliance. You will collaborate with Engineering, Operations, Regulatory, R&D, and Quality teams to deliver projects on time, within scope and budget,

Qualifications

• Bachelor's degree in Science (Chemistry, Biology, Engineering) required.
• 3+ years in a quality role within manufacturing.
• ETO/steam/gamma sterilization experience preferred.
• Strong knowledge of FDA and ISO 13485 quality systems.

Responsibilities

• Lead sterilization quality initiatives across manufacturing sites.
• Coordinate sterilization validation activities and revalidations.
• Authors/approves sterilization protocols and validation reports.
• Ensure compliance with FDA/ISO 13485 and cGMP requirements.
• Lead and manage cross-functional sterilization and quality improvement projects.
• Develop project charters, timelines, resources, and budgets.

Skills

Project management

LEAN manufacturing

Six Sigma

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in Science (Chemistry, Biology, Engineering)

Tools

SAP

MS Office

Job description

West Pharmaceutical Services, Inc. in Exton, PA is seeking a Quality Project Manager – Sterilization to lead sterilization quality initiatives across multiple sites, focusing on EtO, steam, and gamma processes within FDA and ISO 13485 frameworks.

The role drives standardization, validation programs, and QMS improvements while ensuring regulatory compliance. You will collaborate with Engineering, Operations, Regulatory, R&D, and Quality teams to deliver projects on time, within scope and budget,