In één oogopslag
- Taken: Leid de kwaliteitscontrole van wereldwijde distributiecentra en zorg voor naleving van regelgeving.
- Bedrijf: Een toonaangevend bedrijf in de medische technologie met een focus op patiëntenzorg.
- Voordelen: Aantrekkelijk salaris, professionele ontwikkeling en een impactvolle rol in de gezondheidszorg.
- Overige informatie: Dynamische werkomgeving met mogelijkheden voor persoonlijke groei en ontwikkeling.
- Waarom deze baan: Maak een verschil in de kwaliteit van medische apparaten wereldwijd en werk samen met diverse teams.
- Kwalificaties: Bachelor's degree en 12-15 jaar ervaring in kwaliteitsborging binnen gereguleerde omgevingen.
Het verwachte salaris ligt tussen 47385 - 57915 € per jaar.
Overview
In this role you ensure end-to-end quality oversight of global distribution centers, 3PLs, and post-sterilization testing to keep finished medical devices compliant and readily available.
You partner with Operations, Quality, Supply Chain, Sterilization, and Regulatory Affairs to manage risk, audit readiness, and continuous improvement across the global network.
You will lead quality governance for GDP, 3PL oversight, and post-sterilization activities while aligning testing strategies with regulatory expectations.
This position offers impact across regions, shaping distribution quality and risk management in a complex, regulated environment.
- You will work in a mission-driven, patient-focused
- Verantwoordelijkheden
- Provide quality leadership and governance for global distribution centers and 3PLs to ensure GDP and regulatory compliance
- Establish and harmonize distribution quality standards, procedures, and metrics across regions
- Manage quality agreements with all 3PL partners
- Oversee distribution-related deviations, nonconformances, CAPAs, and change controls with timely investigations and risk mitigation
- Coordinate post-sterilization laboratory testing with internal and external labs
- Ensure testing strategies, sampling plans, and release activities meet validated processes and regulatory expectations
- Review and trend post-sterilization test results to identify risks and drive improvements
- Collaborate with Sterilization, Manufacturing, and Regulatory teams on release decisions and investigations
- Ensure compliance with global regulations including 21 CFR 820, ISO 13485, MDSAP and GDP requirements
- Support audits and regulatory inspections; drive inspection readiness across distribution sites and partners
- Define and monitor KPIs for distribution and post-sterilization quality performance
- Lead continuous improvement initiatives to reduce deviations, shorten cycle times, and strengthen risk-based decision making
- Promote a culture of quality, accountability, and proactive risk management across internal teams and external partners
- Lead and develop global distribution quality team members; serve as primary quality interface with cross-functional stakeholders
- Provide escalation, decision-making, and communication during quality events affecting supply continuity
- Perform other duties as assigned
- Belangrijkste vereisten
- Bachelor’s degree in a relevant field with 12–15 years of related experience
- Significant experience in Quality Assurance within a regulated medical device or pharmaceutical environment
- 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
- Agile adaptability
- Customer-centric mindset
- People-focused leadership
- GDP compliance
- Regulatory affairs knowledge (FDA, ISO, MDSAP)
- Post-sterilization testing and validation
Global Quality Distribution Manager in Roosendaal werkgever: Jobrapido
StarPark is een uitstekende werkgever die je de kans biedt om te werken op diverse evenementen en festivals, waar je in een informele en prettige werksfeer kunt bijdragen aan de veiligheid van bezoekers. Met flexibele werkmogelijkheden en goede begeleiding vanuit het team, stimuleert StarPark persoonlijke groei en ontwikkeling, waardoor je niet alleen waardevolle ervaring opdoet, maar ook de mogelijkheid hebt om door te groeien binnen de organisatie. Wij verwelkomen iedereen, ongeacht achtergrond, en geloven dat jouw talent het belangrijkste is.
