Santen is a specialized company with a rich 130-year history dedicated to eye health. Operating globally in over 60 countries, our mission is to provide significant value to patients and society through our expertise in ophthalmology.

The Role

In your role as Quality Lead, Distribution EMEA & Benelux, you will be responsible for ensuring that all quality-related activities associated with Good Distribution Practice (GDP) are effectively executed across Santen SA/NL and the Benelux cluster. You will lead quality oversight for distribution activities across Santen’s EMEA product portfolio and act as (Deputy) Responsible Person (RP).

Responsibilities

• Lead and ensure execution of GDP-related operational quality activities across Santen SA/NL and Benelux.
• Drive end-to-end distribution quality oversight for medicinal products, medical devices, and nutritional products across EMEA.
• Act as (Deputy) Responsible Person (RP) for Santen SA/NL.
• Oversee and manage quality performance of third-party partners (3PLs, CDOs, freight forwarders).
• Ensure effective qualification, monitoring, and continuous improvement of distribution partners.
• Maintain and enhance GDP and ISO 13485-compliant quality systems.
• Lead or support regulatory inspections (Notified Bodies, health authorities, ISO audits).
• Manage and approve deviations, investigations, CAPAs, and change controls.
• Investigate distribution issues such as temperature excursions.
• Facilitate and document Quality Management Reviews in line with regulatory requirements.
• Analyze KPIs and quality metrics to drive continuous improvement.
• Maintain quality agreements and support decision-making related to deviations.
• Lead or participate in internal and external audits.
• Act as quality representative for cross-functional and EMEA projects.
• Promote a strong quality culture and mindset across the organization.

Requirements

• 3–5 years of experience in Quality within the pharmaceutical industry.
• Proven experience with GDP requirements and compliance.
• Experience in auditing.
• Experience in distribution, logistics, or supply chain quality (preferred).
• Strong knowledge of GDP/GMP regulations and quality systems.
• Analytical and investigative mindset with strong problem-solving skills.
• Excellent communication and stakeholder management skills.
• Ability to work cross-functionally in an international environment.
• High level of ownership, urgency, and accountability.
• Strong focus on patient safety and compliance excellence.
• Bachelor's or Master’s degree in Pharmacy, Chemistry, Biology, or Life Sciences.
• Advanced knowledge of quality management systems and GDP standards.

Nice to Have

• Fluent in English (required).
• Dutch language skills (desirable).

What We Offer

• Base salary range of EUR 67.819 - EUR 93.251 gross/year depending on experience.

Grow your career at Santen and make a difference. We are committed to being a Social Innovator, addressing the needs of people with visual impairments. Join us in our mission to empower team members with flexible working options and an inclusive environment.