Oversee globally aseptic practices in the steriles manufacturing network.
Ensure adherence to evolving expectations from Health Authorities.
Create a sterility assurance program and ensure implementation in accordance with Viatris regulatory standards.
Focus on the sterility assurance culture, operations and awareness to improve the batch success rate and contamination control.
Work with Site and Global stakeholders to maintain and update the aseptic education and awareness training program.
Provides sterility assurance expertise on facility designs, flows, zone concepts, investigations, and new product introductions/tech transfers.

Strong understanding of USP and EP, endotoxin, and sterility testing is required.
Comprehensive understanding of the major Regulations and Guidelines pertaining to the pharmaceutical industry.
Specifically GMP compliance knowledge including 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance.
Hands-on experience in complex investigations in both preventive and reactive contamination control.
Knowledge and experience in microbiological test technologies, efficacy studies and recovery methods.
Strong regulatory understanding of environmental monitoring programs that can will enable proactive assessment of controls prior to exceeded action limits.
Technical knowledge of clean room engineering including particle control mechanisms.

Senior Director, Global Sterility Assurance

About this role