Dual RP/QP Compliance Leader — Pharma

Alliance Unichem Ip Limited; Netherlands; Hybrid; EUR 110,000 - 170,000; Full time

Job summary

Cencora is seeking a combined Responsible Person (RP) and Qualified Person (QP) in the Netherlands for a hybrid role with GDP-focused RP (~80%) and GMP-focused QP (~20%). You will ensure full regulatory compliance under Dutch law and EU GMP, with IGJ oversight.

The RP duties cover GDP compliance, supplier and distribution controls, CAPAs, recalls, and training, while the QP duties cover batch release, deviations, PQRs, and GMP documentation. A life sciences degree is required.

Qualifications

• Demonstrated experience in GDP and GMP
• Proven experience working with or under supervision of IGJ
• Strong knowledge of EU pharmaceutical legislation and Dutch regulatory framework (including Opiumwet, WDA)
• Experience with regulatory inspections and audits
• Eligible to act as both RP under GDP and QP under Directive 2001/83/EC
• University degree in Pharmacy, Chemistry, Biology, or related life sciences discipline

Responsibilities

• Act as the legally appointed RP for GDP and Dutch legislation
• Ensure GDP compliance for medicinal products, APIs, and controlled substances
• Maintain and improve the QMS in line with GDP and IGJ expectations
• Ensure compliance with Wholesale Distribution Authorisation (WDA)
• Dispostition of returned, rejected, falsified, or recalled products
• Approve reintroduction of products into saleable stock
• Oversee GDP-relevant outsourced activities
• Qualify suppliers, customers, and transportation partners
• Oversee complaint handling and deviation management
• Execute self-inspections and implement CAPAs
• Act as primary contact for IGJ GDP inspections
• Ensure compliance with Opium Act where applicable
• Coordinate and manage product recalls in the Netherlands
• Train and maintain GDP/API training programs
• Act as Qualified Person under EU Directive 2001/83/EC
• Certify and release medicinal product batches per EU GMP (Annex 16 and Annex 21)
• Ensure products are released only when meeting regulatory and quality requirements
• Maintain GMP oversight 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 up to date
• Assess and approve suppliers/contractors from GMP perspective with RP
• Escalation point to senior management on GMP risks

Skills

GDP

GMP

IGJ experience

EU pharmaceutical legislation

Regulatory inspections

Education

University degree in Pharmacy, Chemistry, Biology, or related life sciences

Job description

Cencora is seeking a combined Responsible Person (RP) and Qualified Person (QP) in the Netherlands for a hybrid role with GDP-focused RP (~80%) and GMP-focused QP (~20%). You will ensure full regulatory compliance under Dutch law and EU GMP, with IGJ oversight.

The RP duties cover GDP compliance, supplier and distribution controls, CAPAs, recalls, and training, while the QP duties cover batch release, deviations, PQRs, and GMP documentation. A life sciences degree is required.