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.
The Director, Global Sterility Assurance is responsible for governance and oversight of all sterilization modalities (e.g., EtO, gamma, e‑beam, moist heat, dry heat, hydrogen peroxide, sterile filtration, aseptic processing), all environmental monitoring programs and strategies at global sites, internal manufacturing sites and external sterilization suppliers, new product introductions, validations, routine operations, deviations, lifecycle changes, and global regulatory and standards compliance (FDA, ISO, EU MDR, etc.).
Knowledge, 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
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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.
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Experience:
- 15+ years of experience in the Medical Device Industry.
7+ years of managerial experience with global responsibility.
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Education:
- Bachelor’s degree in Microbiology, Biology, Biomedical Engineering, or related scientific discipline required. Advanced degree preferred.
Essential 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
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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
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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
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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
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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
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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
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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
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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
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Travel: This position may require 20-30% domestic or international travel.
