Senior Director, Global Sterility Assurance

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Oversee global aseptic practices within the sterile manufacturing network.

• Ensure compliance with the evolving expectations set by Health Authorities.

• Develop a sterility assurance program and guarantee its execution according to Viatris regulatory standards.

• Emphasize a culture of sterility assurance, operations, and awareness to enhance batch success rates and control contamination.

• Collaborate with Site and Global stakeholders to sustain and refresh the aseptic education and awareness training program.

• Provide expertise in sterility assurance regarding facility designs, workflows, zone concepts, investigations, and new product introductions/technology transfers.

⛳️ Requirements

• In-depth knowledge of USP and EP standards, endotoxin, and sterility testing is essential.

• Thorough understanding of the key Regulations and Guidelines related to the pharmaceutical industry.

• Specifically, knowledge of GMP compliance including 21CFR210, 211, 820, and the PICS Guide to Good Manufacturing Practices Parts 1 and 2, or the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, including Annex 1, and FDA Guidance on Aseptic Processing; as well as ISO 9001:2015, 13485, and Part 11 compliance.

• Practical experience in intricate investigations concerning both preventive and reactive contamination control.

• Familiarity and experience with microbiological testing technologies, efficacy studies, and recovery methods.

• Strong regulatory knowledge of environmental monitoring programs to enable proactive evaluation of controls before action limits are exceeded.

• Technical expertise in clean room engineering, including particle control mechanisms.

🏝️ Benefits

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension