Sterility Assurance Manager - WALKER COLE INTERNATIONAL LTD : Job Details

Walker Cole International is seeking a Sterility Assurance Manager to join a leading biopharmaceutical organisation in Reykjavik, Iceland. This full-time role offers an exciting opportunity to lead sterility assurance initiatives, ensuring compliance and quality in a highly regulated environment.

Key Responsibilities as the Sterility Assurance Manager:

• Develop and oversee the site Sterility Assurance Program and microbial control strategies across production processes.
• Provide expertise in aseptic processing, supporting operations and ensuring compliance with international standards.
• Act as a subject matter expert (SME) during regulatory and client audits.
• Lead and mentor the Sterility Assurance team to achieve production and quality goals.

To be successful in your application for the Sterility Assurance Manager position, you will have the following expertise:

• MSc or equivalent in a relevant scientific discipline, with extensive industry experience.
• In-depth knowledge of cGMP standards and aseptic processing.
• Proven leadership skills with the ability to motivate and develop a team.
• Expertise in microbial control and sterility assurance within a manufacturing environment.

Regulatory Affairs | Sterility Assurance | Aseptic Processing | cGMP | Biopharmaceuticals | Quality Management | Reykjavik Iceland | Leadership | Microbial Control | GMP Compliance