Job DescriptionThe 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.
ResponsibilitiesEssential Functions & Accountabilities:Global Sterility Governance & Strategy
- Define and maintain the global sterility assurance strategy, policies, and standards
- Establish a harmonized approach to sterilization, contamination control, and sterility assurance across the enterprise
- Serve as the final Quality authority for sterility related decisions, independent of production pressures
- End-to-end Sterilization Process Oversight
Provide Quality review and approval for:
- Sterilization cycle design, development, and optimization
- Validation and requalification activities (IQ/OQ/PQ)
- Routine monitoring, trending, and performance reviews
- Ensure sterilization processes remain in a demonstrated state of control throughout the product lifecycle
- Govern change management and revalidation decisions related to sterilization and sterile barrier systems
Environmental Monitoring & Contamination Control Oversight
- Provide enterprise oversight of environmental monitoring (EM) programs supporting sterile and aseptic operations
- Ensure EM strategies are risk-based and aligned with cleanroom classification, sterilization modality, and contamination control strategy
- Review EM data and trends to identify emerging risks and ensure timely investigation and remediation
Compliance, Risk Management & Inspection Readiness
- Ensure compliance with applicable regulations and standards, including but not limited to:
- 21 CFR 820, ISO 13485
- ISO 11135, ISO 11137, ISO 17665
- ISO 11737, ISO 14644, ISO 14971
- ISO 13408, EU MDR
Serve as Quality lead for sterility-related:
- Regulatory inspections and audits
- Internal audits and risk assessments
- Responses to observations, commitments, and remediation plans
- Drive enterprise sterility risk identification, escalation, and resolution
External Supplier & Partner Oversight
- Provide Quality governance of contract sterilization providers, including:
- Supplier qualification and ongoing performance monitoring
- Review and approval of validation and routine process documentation
- Issue escalation, investigation support, and remediation oversight
Quality Systems & Continuous Improvement
- Lead or oversee sterility-related deviations, investigations, and CAPAs
- Ensure procedures, work instructions, and training reflect current regulatory expectations and best practices
- Sponsor continuous improvement and harmonization initiatives across sites
Leadership & Capability Building
- Build, lead, or govern a global Sterility Assurance team and community of SMEs
- Provide mentoring and technical leadership to site Quality, Microbiology, and Engineering teams
- Advance organizational knowledge and capability in sterility assurance and contamination control
Travel: This position may require 20-30% domestic or international travel.
QualificationsKnowledge, Skills and Abilities:- Extensive experience in sterilization and sterility assurance within a regulated industry (medical device, pharma, or combination products)
- Demonstrated leadership in Quality, Sterility Assurance, Microbiology, or Validation
- Deep working knowledge of global sterilization standards and regulatory expectations
- Proven experience serving as a sterility authority during regulatory inspections
Work Environment:- Production Area/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
- Occasionally lift to 35 pounds.
Experience:- 15+ years of experience in the Medical Device Industry.
- 7+ years of managerial experience with global responsibility.
Education:- Bachelor's degree in Microbiology, Biology, Biomedical Engineering, or related scientific discipline required. Advanced degree preferred.
