Responsible Person & Qualified Person - Wholesale Affairs Netherlands

We are seeking a highly qualified professional to take on a combined Responsible Person (RP) and Qualified Person (QP) position within our organization in the Netherlands.

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.

Full time

Affiliated Companies

Affiliated Companies: Alliance Healthcare Management Services Limited

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned