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Sterility Assurance and Microbiology Global Expert - Remote

Posted 3 weeks ago
All others
Full Time
MA, USA
$148,125.00 - $213,958.33/year

Overview

The Sterility Assurance and Microbiology Global Expert will manage global expertise for Sterility Assurance & Microbiology, providing strategic view and technical expertise to improve compliance and efficiency across Sanofi business units.

In Short

  • Manage global expertise for Sterility Assurance and Microbiology.
  • Provide technical guidance on drug and sterile manufacturing.
  • Develop and maintain standards for sterility assurance.
  • Lead cross-functional teams to achieve contamination control objectives.
  • Support regulatory inspections and compliance.
  • Interact with external bodies for knowledge exchange.
  • Drive continuous improvement initiatives across sites.
  • Collaborate with Digital and Quality functions.
  • Analyze and propose initiatives for best practices.
  • Ensure compliance with current and future regulatory requirements.

Requirements

  • BS or MS in Microbiology, Biochemistry, or related field.
  • Minimum 15 years of experience in Pharmaceutical/Biotech Sterile Manufacturing.
  • Strong quality mindset and compliance management experience.
  • Expertise in contamination control and quality risk management.
  • Knowledge of aseptic processes and microbiological testing.
  • Strong analytical and problem-solving skills.
  • Proven ability to lead cross-functional teams.
  • Prior experience in Pharmaceutical Industry Committees is preferred.

Benefits

  • Opportunities for career growth and development.
  • Comprehensive health and wellness benefits.
  • At least 14 weeks of gender-neutral parental leave.
  • Supportive and inclusive work environment.
  • Competitive rewards package.

.G.C

(5100) Genzyme Corporation

Genzyme Corporation, a part of Sanofi, is a global biopharmaceutical company dedicated to transforming the lives of individuals facing immune challenges, rare diseases, blood disorders, cancers, and neurological disorders. With a commitment to innovation, Genzyme focuses on developing and delivering cutting-edge treatments that address unmet medical needs. The company fosters collaboration among talented teams across research and development, sales, and medical affairs to enhance the understanding and value of its products. Genzyme is dedicated to making a significant impact on the health and well-being of patients worldwide, while promoting a diverse and inclusive workplace that supports the growth and development of its employees.

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