Quality Lead, Distribution EMEA & Benelux

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 Santens 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 nutritionals 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

• 35 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

• Bachelors or Masters 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.

Remote Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1