Responsible Person & Qualified Person – Hybrid Role (Wholesale AH NL)

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

We are seeking a highly qualified professional to take on the Responsible Person & Qualified Person – Hybrid Role (Wholesale AH NL) position within our organization in the Netherlands.

• Location: Veghel, Netherlands
• This is a hybrid role.
• Full time

Job Details

This is a hybrid role with a clear split in responsibilities:

• ~80% Responsible Person (GDP-focused)
• ~20% Qualified Person (GMP-focused)

In this role, you will ensure full compliance with Dutch regulatory requirements and European legislation, including oversight by the Dutch Health and Youth Care Inspectorate (IGJ).

Responsabilities:

Responsible Person (RP) – GDP Responsibilities (~80%)

• Act as the legally appointed Responsible Person in accordance with GDP (2013/C 343/01) and applicable Dutch legislation
• Ensure that medicinal products, APIs, and controlled substances are received, stored, and distributed in full compliance with GDP
• Maintain and continuously improve the Quality Management System (QMS) in line with GDP and IGJ expectations
• Ensure that all activities performed under the Wholesale Distribution Authorisation (WDA) are compliant
• Take final responsibility for:

• Disposition of returned, rejected, falsified, or recalled products
• Approval of reintroduction of products into saleable stock
• Approval and oversight of GDP-relevant outsourced activities

• Ensure:

• Qualification of suppliers, customers, and transportation partners
• Effective complaint handling and deviation management
• Execution of self-inspections and implementation of CAPAs
• Act as the primary contact for GDP-related inspections by IGJ
• Ensure compliance with Dutch Opium Act (Opiumwet) where applicable
• Coordinate and manage product recalls in the Netherlands
• Ensure that training programs (GDP/APIs) are implemented and maintained

Qualified Person (QP) – GMP Responsibilities (~20%)

• Act as a Qualified Person in accordance with EU Directive 2001/83/EC
• Certify and release medicinal product batches in compliance with EU GMP (including Annex 16 and Annex 21)
• Ensure that products are released only when they meet all regulatory and quality requirements
• Maintain oversight of GMP-compliant processes across packaging, importation, and related activities
• Support and/or lead GMP inspections and audits (including IGJ inspections)
• Review and approve:

• Batch documentation
• Deviations, investigations, and CAPAs
• Product Quality Reviews (PQRs)

• Ensure GMP documentation (SOPs, validation, specifications) is compliant and up to date
• Assess and approve suppliers and contractors from a GMP perspective, in close collaboration with the RP
• Act as escalation point to senior management / Managing Director on GMP compliance risks

Requirements:

• Demonstrated experience in:

• GDP (Good Distribution Practice)
• GMP (Good Manufacturing Practice)
• Proven experience working with or under supervision of IGJ (Inspectie Gezondheidszorg en Jeugd)
• Strong knowledge of:

• EU pharmaceutical legislation
• Dutch regulatory framework (including Opiumwet, WDA)
• Experience with regulatory inspections and audits

Minimum skills required:

• Eligible to act as both:

• Responsible Person (RP) under GDP
• Qualified Person (QP) under Directive 2001/83/EC
• University degree in Pharmacy, Chemistry, Biology, or related life sciences discipline

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.