Global Manager, Distribution & Sterilization Quality

Company:
Hollister Incorporated

Locations:
Mt. Juliet, TN (ZIP 37122);
Roosendaal, Netherlands (ZIP 4879). We will consider applicants based at these locations.

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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.

• 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.

• Communicate effectively via email, phone, and virtual platforms.
• Collaborate across departments to support organizational goals.
• Participate in cross‑functional meetings and initiatives.
• Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
• Prepare reports and dashboards for internal stakeholders.
• Ensure data accuracy and confidentiality in compliance with company and legal standards.
• Manage multiple priorities and deadlines in a fast‑paced environment.
• Lead or support special projects aligned with departmental objectives.
• Demonstrate initiative in identifying process improvements or automation opportunities.
• Serve as a point of contact for internal and external stakeholders.
• Resolve inquiries and issues with professionalism and discretion.
• Adhere to company policies, including those related to ADA, data privacy, and ethics.
• Maintain secure handling of sensitive information.
• Support audits and regulatory reporting as needed.
• Oversight of compliance, risk, and organizational culture.

• Bachelor’s Degree with 12–15 years of…