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Integraleaf logo
Integraleaf

Wir helfen Ihrem Unternehmen in Deutschland erfolgreich zu werden.

Senior Consultant – Qualified Person, Pharma & Cannabis

Location

Germany

Posted

58 days ago

Salary

€40K - €110K / year

Seniority

Senior

Bachelor Degree3 yrs expGermanEnglish

Job Description

Senior Consultant – Qualified Person, Pharma & Cannabis

Integraleaf

• You take responsibility as Qualified Person in accordance with §15 AMG, ensuring the proper manufacture and release of medical cannabis • You act as the Responsible Person under the MedCanG and ensure compliance with all relevant regulatory requirements • You advise national and international clients on GMP and regulatory matters — pragmatic and solution-oriented • You serve as the primary contact for authorities and support inspections and audits • You deliver training for clients and internal teams, communicating regulatory requirements clearly and practically • You support the establishment, further development and optimization of quality management systems • You work closely with internal and external stakeholders and ensure clear, efficient communication

Job Requirements

  • Qualification as a Qualified Person pursuant to §15 AMG or the formal prerequisites for this qualification
  • University degree in Pharmacy, Chemistry, Biology or a related discipline
  • Several years of professional experience in the pharmaceutical industry, ideally in quality assurance, production or quality control
  • Solid, practical knowledge of EU-GMP regulations
  • Experience interacting with regulatory authorities and supporting inspections or audits
  • Strong decisiveness and a high sense of responsibility in a regulated environment (particularly regarding release decisions)
  • Structured, independent working style in a remote setup
  • Business-fluent German and English, both written and spoken
  • Residence and permanent right to work in Germany
  • Willingness to travel occasionally (within Germany and internationally)
  • Willingness to record time accurately for individual projects
  • Ideally, you also bring: experience as a named Qualified Person (QP) in a pharmaceutical company
  • Practical experience in establishing, further developing or auditing Quality Management Systems (QMS)
  • Experience supporting or leading regulatory inspections (e.g., EU-GMP, national authorities)
  • Knowledge of the regulatory environment for medical cannabis or similarly highly regulated areas
  • Experience advising or managing multiple clients/projects in parallel
  • Confident application of risk-based decision-making approaches (e.g., in the context of releases or deviations)
  • Openness to using digital tools and AI-based solutions to increase efficiency in daily work

Benefits

  • 100% remote within Germany — no office, no mandatory on-site presence
  • Flexible working hours with no fixed core hours
  • High degree of autonomy in shaping your working day
  • Challenging QP responsibility without classic corporate structures
  • Focus on technical work — no sales or business development obligations
  • Collaboration with experienced colleagues in the GMP and QP environment
  • Stable workload due to existing client projects
  • Permanent employment with predictable income (no freelancer risks)
  • Opportunity to actively shape quality standards and processes
  • Variety through collaboration with different companies
  • Work in a growing, highly regulated market (focus: medical cannabis)
  • Flexible start date — short notice possible
  • Lean structures and short decision-making paths
  • 30 days of vacation with flexible use
  • No systematic expectation of overtime
  • Option for performance-based profit sharing with appropriate development
  • Significant decision-making authority within the scope of your professional responsibilities
  • Collegial collaboration without traditional hierarchies or micromanagement

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