Responsible Person (RP) | Specialty Pharmaceuticals | Berlin, Germany
Allerton Bishop is delighted to be partnering with a growing international specialty pharmaceutical and wholesale organisation to appoint a Responsible Person (RP) for its operations in Germany.
This is an excellent opportunity for an experienced RP to take ownership of wholesale distribution compliance within a dynamic business focused on the supply of specialty medicines across European markets. Working within a collaborative leadership team, you will play a critical role in ensuring the highest standards of GDP compliance, quality assurance and patient safety.
The Opportunity
The Responsible Person will oversee all GDP-related quality activities across the wholesale distribution operation, ensuring compliance with EU GDP Guidelines, German regulatory requirements and internal quality systems.
The successful candidate will act as the named Responsible Person for the licensed wholesale business, providing expert guidance on quality and regulatory matters while supporting business growth, operational excellence and continuous improvement.
Key Responsibilities
- Act as the named Responsible Person (RP) for the wholesale distribution authorisation.
- Ensure full compliance with EU GDP Guidelines and German wholesale distribution regulations.
- Oversee the Quality Management System (QMS), including deviations, CAPAs, change controls and risk management activities.
- Review and approve suppliers, customers and distribution partners to ensure supply chain integrity.
- Support regulatory inspections and manage interactions with competent authorities.
- Lead GDP training programmes and promote a culture of quality throughout the organisation.
- Work closely with Supply Chain, Regulatory Affairs, Commercial and Operations teams to support compliant business growth.
Candidate Profile
We're interested in speaking with quality professionals who possess:
- Eligibility to act as a Responsible Person (RP) under German regulatory requirements.
- Proven experience within pharmaceutical wholesale distribution or specialty pharmaceutical businesses.
- Strong working knowledge of EU GDP Guidelines and pharmaceutical quality systems.
- Experience supporting regulatory inspections and maintaining wholesale distribution licences.
- Excellent understanding of supply chain quality, vendor qualification and risk management.
- Strong communication skills with the ability to influence stakeholders across multiple functions.
- Fluent German and English language skills are Essential.
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