Global Sterility Assurance Systems – Standards Specialist

Role Overview

• Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
• Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance
• Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site
• Partners closely with the global function leads as well as site leadership team, develops strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements
• Provides expert input to Sterility Assurance related major deviation investigations in the area of sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail
• Plays a proactive role in the investigation of accidents and near misses as well as in the implementation of corrective actions
• Proactively works with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections)
• Provides CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence…)
• Provides strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design)
• Develops and leads Sterility Assurance Roadmaps for compliance and performance
• Ensures appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.

Requirements

• Bachelor's degree in Microbiology or Biology or life sciences or equivalent relevant field
• 8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance context
• Demonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelines
• Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development opportunities