Director, Global Sterility Assurance and Environmental Monitoring
About The Position
The Director, Global Sterility Assurance and Environmental Monitoring is accountable for enterprise-wide governance, oversight, and technical authority for all sterilization, sterility assurance, and environmental monitoring activities. This role leads a centralized sterility and environmental monitoring function responsible for reviewing, approving, and maintaining control of sterilization and environmental monitoring processes across their full lifecycle, from design and validation through routine manufacturing, change management, and remediation. This position serves as the global authority for sterility assurance, ensuring products are manufactured in a validated state of control, risks are proactively managed, and regulatory expectations are consistently met across internal manufacturing sites and external contract sterilization providers.
Requirements
- Technical authority for sterilization, sterility assurance, and environmental monitoring.
- Experience with sterilization processes.
- Experience with sterility assurance.
- Experience with environmental monitoring.
- Experience with process lifecycle management (design, validation, routine manufacturing, change management, remediation).
- Experience managing risks.
- Knowledge of regulatory expectations.
- Experience working with internal manufacturing sites.
- Experience working with external contract sterilization providers.
Responsibilities
- Enterprise-wide governance, oversight, and technical authority for all sterilization, sterility assurance, and environmental monitoring activities.
- Lead a centralized sterility and environmental monitoring function.
- Review, approve, and maintain control of sterilization and environmental monitoring processes across their full lifecycle (design, validation, routine manufacturing, change management, remediation).
- Serve as the global authority for sterility assurance.
- Ensure products are manufactured in a validated state of control.
- Proactively manage risks.
- Ensure regulatory expectations are consistently met across internal manufacturing sites and external contract sterilization providers.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
