Global Manager, Distribution & Sterilization Quality

Summary

The Global Manager, Distribution & Sterilization Quality is responsible for providing end‑to‑end quality oversight of global distribution centers, third‑party logistics providers (3PLs), and post‑sterilization laboratory testing activities. This role ensures that finished medical devices are stored, handled, tested, and distributed in full compliance with applicable regulatory and quality system requirements, while supporting uninterrupted product supply to patients and customers.

The role partners closely with Operations, Quality, Supply Chain, Sterilization, and Regulatory Affairs to manage risk, ensure audit readiness, and continuously improve distribution and post‑sterilization quality processes across the global network.

Responsibilities

• Provide quality leadership and governance for global distribution centers and third‑party logistics providers, ensuring compliance with Good Distribution Practices (GDP) and applicable medical device regulations.
• Establish, maintain, and harmonize distribution quality standards, procedures, and metrics across regions.

• Ensure effective quality agreements are in place and maintained with all 3PL partners.
• Oversee distribution‑related deviations, nonconformances, CAPAs, and change controls, ensuring timely investigation and effective risk mitigation.
• Oversee post‑sterilization laboratory testing activities, including coordination with internal and external laboratories.
• Ensure testing strategies, sampling plans, and release activities align with validated processes, regulatory expectations, and product risk.
• Review and trend post‑sterilization test results to identify emerging risks and drive continuous improvement.
• Partner with Sterilization, Manufacturing, and Regulatory teams on product release decisions and investigations.
• Ensure distribution and post‑sterilization processes comply with applicable global regulations and standards, including 21 CFR 820, ISO 13485, MDSAP, and regional, local GDP requirements.
• Support internal, external, and regulatory audits related to distribution, logistics, and post‑sterilization activities.
• Drive inspection readiness across distribution sites and logistics partners.
• Define and monitor KPIs for distribution and post‑sterilization quality performance.
• Lead continuous improvement initiatives to reduce deviations, improve cycle times, and strengthen risk‑based decision making.

• Promote a culture of quality, accountability, and proactive risk management across internal teams and external partners.

  People & Stakeholder Leadership

  • Lead and develop global distribution quality team members, where applicable.
  • Serve as the primary quality interface with Supply Chain, Logistics, Operations, Sterilization, and Regulatory Affairs.
  • Provide clear escalation, decision‑making, and communication during quality events impacting supply continuity.

Other duties as assigned.

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• Bachelor’s degree in engineering, Life Sciences, or related field (advanced degree preferred).
• 12+ years Significant experience in Quality Assurance within a regulated medical device or pharmaceutical environment.
• Demonstrated experience with distribution quality, GDP, logistics, and third‑party oversight.
• Working knowledge of sterilization processes and post‑sterilization testing requirements.
• Strong understanding of global regulatory requirements (FDA, ISO, MDSAP).
• Proven ability to lead cross‑functional teams and manage quality risk in complex global networks.

Competencies