Qualified Person - Medical Cannabis Germany

Qualified Person - Medical Cannabis Germany

Industry: Pharmaceutical Wholesale, Distribution, Import & (GMP) Processing

Sector: Medical Cannabis

Location: Thuringia, Germany

Employment Type: Full-time

Work Model: On-site ideally 2 - 3 days/week (flexible arrangement possible)

About the Company

Our client is a fully licensed importer, distributor, and manufacturer in the German medical cannabis sector, operating in full alignment with EU-GMP and GDP standards headquartered in Thuringia, and part of a Swiss-based group with broader capabilities across the cannabis value chain.

The company is currently in a high-growth phase, shifting from an initial focus on cultivation readiness and product quality to a broader, scalable commercial model. In addition to importing products, the next phase includes building out their warehouse and dedicated GMP environment in Thuringia, enabling packaging, labeling, and enhanced processing workflows, potentially alongside specialist partner companies.

The internal team is lean, entrepreneurial, and highly collaborative, with a strong expectation of a pragmatic, solution-oriented mindset in a fast-moving and tightly regulated market.

Position Overview

The Qualified Person (QP) assumes legal responsibility under §14 AMG for pharmaceutical quality and regulatory compliance of all medicinal cannabis batches imported, processed, packaged, and distributed by the company.

While the business continues to work with an experienced external QP to assist this role, increasing product volume, supplier onboarding, approvals, and upcoming operational expansion require a more available, hands‑on QP presence. This role is designed to be a critical internal anchor for batch release, supplier qualification, change control, and the day‑to‑day quality decisions that enable speed and flexibility in the medical cannabis market. A successful integration into the organisation is expected within approximately six months.

Key Responsibilities:

Batch Certification & Release

• Certify and release medicinal cannabis batches in line with AMG, EU-GMP (Part I/II), Annex 16, and applicable cannabis/narcotics regulations.
• Review and approve batch documentation (e.g., BMR/BPR, deviations, CoAs, stability data).
• Ensure EU‑GMP compliance of imported products, including oversight of third‑country manufacturers where relevant.
• Lead and support the qualification of new cultivators, processors, CMOs, and testing partners.
• Drive timely product approvals to reduce bottlenecks in a dynamic and competitive market.

QMS & Documentation

• Approve and maintain SOPs, validations, change controls, CAPAs, and related QMS documentation.
• Ensure documentation integrity in line with Annex 11/15 where applicable.

Audits & Inspections

• Support and prepare for inspections by relevant authorities (e.g., regional authorities, BfArM).
• Conduct internal audits and support audits of external suppliers/manufacturers.

Cross-Functional Leadership

• Provide daily quality oversight across QA, Supply Chain, Operations, RA and external partners.
• Act as an accessible internal decision‑maker for quality‑driven commercial execution.

Candidate Profile:

Requirements

• Fully eligible to act as Qualified Person under §14 AMG.
• University degree in Pharmacy or another recognised life‑sciences discipline with QP eligibility.
• 3–5+ years relevant GMP experience in pharmaceuticals.
• Strong working knowledge of EU‑GMP, GDP, AMG, and ideally BtMG/BtMVV.
• Fluent German (C1+) and professional English.

Strongly Preferred

• Experience with medical cannabis or herbal medicinal products.
• Proven exposure to import workflows, labeling/packaging under GMP, or supplier qualification.
• Comfortable operating in lean, fast‑moving environments with high ownership.

Personality / Culture Fit

• Hands‑on, pragmatic, and highly collaborative.
• Clear “can‑do” mindset with strong judgment within regulatory boundaries.
• Confident communicator who enjoys building processes without overcomplicating them.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance, Product Management, and Manufacturing

Industries: Wholesale, Wholesale Import and Export, and Pharmaceutical Manufacturing