Global Distribution Quality Lead (GDP & Sterilization)

Hollister Incorporated; Roosendaal; On-site; EUR 85,000 - 105,000; Full time

Job summary

Hollister Incorporated seeks a Global Manager, Distribution & Sterilization Quality to provide end-to-end quality oversight of global distribution centers, 3PLs and post‑sterilization testing. You will ensure GDP compliance and alignment with regulatory expectations to support uninterrupted product supply.

The role partners with Operations, Quality, Supply Chain, Sterilization and Regulatory Affairs to manage risk, drive continuous improvement, and maintain audit readiness across a global

Qualifications

• Bachelor’s Degree with 12-15 years of related experience.
• 12+ years of 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).

Responsibilities

• Provide quality leadership and governance for global distribution centers and third‑party logistics providers, ensuring GDP compliance.
• Establish and harmonize distribution quality standards, procedures, and metrics across regions.
• Ensure quality agreements with all 3PL partners.
• Oversee distribution‑related deviations, nonconformances, CAPAs, and change controls.
• Oversee post‑sterilization laboratory testing activities and coordination with laboratories.
• Review and trend post‑sterilization test results to identify risks and drive improvements.
• Collaborate with Sterilization, Manufacturing, and Regulatory teams on product release decisions and investigations.
• Maintain compliance with global regulations and standards (FDA, ISO, MDSAP, GDP).
• Support audits and regulatory reporting; drive inspection readiness.

Skills

GDP knowledge

Quality leadership

Regulatory knowledge

Cross-functional leadership

Data analysis

Education

Bachelor’s Degree in Engineering, Life Sciences, or related field

Advanced degree preferred

Tools

Excel

SAP

HRIS

Job description

Hollister Incorporated seeks a Global Manager, Distribution & Sterilization Quality to provide end-to-end quality oversight of global distribution centers, 3PLs and post‑sterilization testing. You will ensure GDP compliance and alignment with regulatory expectations to support uninterrupted product supply.

The role partners with Operations, Quality, Supply Chain, Sterilization and Regulatory Affairs to manage risk, drive continuous improvement, and maintain audit readiness across a global