Qualified Person (QP) / Sachkundige Person (Article 14 AMG)

AMP is an established pharmaceutical wholesaler, importer, distributor, and manufacturer in the German medical cannabis sector, operating in full alignment with EU‑GMP and GDP standards. Based in Thuringia, we manage high‑quality medicinal cannabis products sourced from international partners and ensure compliant processing, packaging, and distribution throughout Germany.

Role Overview

We are looking for a Qualified Person (QP) authorised to bear legal responsibility under 14 AMG for ensuring the pharmaceutical quality and regulatory compliance of all medicinal cannabis batches processed, imported, manufactured, or distributed by the company. This includes batch certification, oversight of GMP/GDP processes, and close collaboration with regulatory authorities and external partners.

Responsibilities

• Batch Certification & Release
• Certify and release medicinal cannabis batches in accordance with AMG, EU‑GMP Part I & II, and Annex 16
• Review and approve batch documentation, including BMR/BPR, deviation reports, CoAs, and stability data
• Ensure imported cannabis batches meet EU‑GMP requirements, including oversight of third‑country manufacturers
• Confirm compliance with narcotics regulations (BtMG, BtMVV) for all released batches
• Maintain oversight of GMP and GDP compliance throughout manufacturing, packaging, storage, and distribution
• Approve and maintain QMS documents including SOPs, validation protocols, and work instructions
• Manage deviation, CAPA, and change control processes
• Support qualification and monitoring of suppliers, CMOs, and testing laboratories
• Prepare for and support regulatory inspections from authorities such as Regierungspräsidium and BfArM
• Conduct internal audits and audits of international cannabis suppliers and contract manufacturers
• Lead follow‑up activities arising from audits and inspections
• Ensure accurate documentation in line with EU‑GMP Annex 11 & 15
• Approve PQR/APR reports and oversee stability management
• Evaluate and resolve OOS/OOT results in collaboration with laboratories
• Provide pharmaceutical oversight across operations teams including QA, Manufacturing, Supply Chain, and RA
• Support regulatory submissions and updates
• Serve as the primary quality authority for internal and external stakeholders

Requirements

• Eligibility as a Qualified Person under 14 AMG
• University degree in pharmacy or other accepted life sciences with QP recognition
• 3‑5 years of GMP experience in pharmaceuticals, ideally involving herbal medicinal products or medical cannabis
• Experience with batch certification, QMS processes, and regulatory interactions
• In‑depth knowledge of EU‑GMP, GDP, AMG, BtMG, and BtMVV
• Strong analytical and decision‑making skills
• Fluent German (C1+) and strong English proficiency

Preferred Qualifications

• Experience in medical cannabis import, testing, or cultivation
• Familiarity with international regulatory frameworks (e.g., Canada, Israel, Australia)
• Prior involvement in EU‑GMP inspections abroad

Benefits

• Working with one of the cannabis industry leaders in Germany
• Professional and supportive team
• Onsite or hybrid work is possible (2 days a week in the office)
• Office location in Erfurt

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Other