Quality Lead, Distribution EMEA & Benelux at Santen

Amsterdam, North Holland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

29 Sep, 26

Salary

93251.0

Posted On

01 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GDP Compliance, GMP Regulations, ISO 13485, Quality Management Systems, Auditing, Stakeholder Management, Problem Solving, Regulatory Compliance, Medical Device Regulation, CAPA Management, Change Control, Supply Chain Quality

Industry

Pharmaceutical Manufacturing

Description

Company Description Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient’s perspective. Job Description As Quality Lead, Distribution EMEA & Benelux, you will ensure that all quality-related activities associated with Good Distribution Practice (GDP) are effectively performed across Santen SA/NL and the Benelux cluster. You will lead quality oversight for end-to-end distribution activities across Santen’s EMEA product portfolio and act as (Deputy) Responsible Person (RP), ensuring full regulatory compliance and the highest standards of product integrity and patient safety. Key Responsibilities GDP Quality Oversight & Distribution 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’s 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 Quality Management System (QMS) 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 Responsible Person (Deputy) Duties Ensure compliance with Wholesale Distribution Authorization (WDA) Approve GDP suppliers, subcontracted activities, and customer qualifications Oversee recall processes and complaint handling activities Conduct self-inspections and audit programs, ensuring timely corrective actions Ensure accurate documentation, traceability, and record-keeping Decide on disposition of returned, rejected, recalled, or falsified products Approve return of products to saleable stock Maintain oversight of delegated RP responsibilities Medical Device Quality Expertise Act as Subject Matter Expert for Medical Device Regulation (MDR) and ISO 13485 Interpret regulatory updates and ensure alignment across relevant functions Qualifications Experience Required 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) Skills & Competencies 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 Education Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or Life Sciences Advanced knowledge of quality management systems and GDP standards Languages English – fluent (required) Dutch – desirable What we offer: The base salary range for the Quality Lead, Distribution EMEA & Benelux position is EUR 67.819 - EUR 93.251 gross/year depending on experience. Additional Information Grow your career at Santen A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment. The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know. Compensation: EUR 67819 - EUR 93251 - yearly

Responsibilities

Lead quality oversight for end-to-end distribution activities across EMEA and act as the Responsible Person for Santen SA/NL. Ensure GDP compliance, manage third-party partners, and maintain quality systems for medicinal products and medical devices.