Director Quality, Regulatory Affairs & Qualified Person (QP)
Location: Densborn, Germany. (Three days a week in the Office required)
Industry: Pharmaceutical & Medical Cannabis Industry
Company Overview:
Our client is a leading German distributor of pharmaceutical and medical cannabis products and a subsidiary of one of North America's largest medical cannabis companies. Founded in the 1990s, they have established a strong reputation for delivering high-quality pharmaceuticals, including medicinal cannabis, to pharmacies and healthcare institutions across Germany. Their unwavering commitment to excellence in pharmaceutical manufacturing and distribution, coupled with stringent adherence to regulatory standards, has positioned them as a trusted partner in the German healthcare industry. The parent company, is one of the world's largest in the medical cannabis sector, employing over 500 people globally. In Germany, our client has a dedicated team of more than 100 workers, with 50 in the Quality/Reg Affairs department you would be leading. You will report directly to the Managing Director located in Germany.
Job Summary:
The Director of Quality, Regulatory Affairs & QP will be responsible for overseeing the entire quality management and regulatory compliance framework for Germany. This role ensures that all medicinal products manufactured & distributed by the client are compliant with
German and EU regulations, and that they are manufactured, tested, and released according to the highest standards. You will be working very closely with the RP to ensure Quality
standards have been met. Ensure that the medicinal products of the client are manufactured, tested, stored, labeled, and documented under the provisions of the AMG and AMWHV, including the EU GMP guidelines, and are provided with the required package insert and released in writing in a continuous register before being placed on the market according to § 16 AMWHV.
Key Responsibilities:
* Quality Management: Oversee the implementation and maintenance of the client's Quality Management System (QMS)in compliance with AMG, AMWHV, and EU GMP guidelines.
* Regulatory Affairs: Ensure all products meet the regulatory requirements for pharmaceutical distribution in Germany, including the submission of necessary documentation to authorities.
* Batch Release: Act as the qualified person (QP) for the client, ensuring that all batches of medicinal products are properly released with the required documentation, labeling, and packaging inserts before distribution.
* Supplier and Partner Audits: Conduct audits of suppliers and contract manufacturers to ensure compliance with GMP standards. Approve new suppliers and monitor
* ongoing relationships.
* Inspection and Audit Management: Coordinate and participate in internal and
* external audits, including those conducted by regulatory authorities. Address and resolve any compliance issues that arise.
* Document Control: Review and approve GMP-relevant Standard Operating Procedures (SOPs), Product Quality Reviews, and the Site Master File.
* Leadership & Advisory: Guide the management team on quality and regulatory matters, ensuring alignment with industry best practices and regulatory changes.
* Pharmaceutical Compliance: Ensure that the client's operations remain compliant with all relevant pharmaceutical laws and regulations, including the AMG and AMWHV.
Qualifications and Experience:
* Must hold a certificate of good conduct and proof of expertise according to § 15 AMG.
* Deep knowledge of current pharmaceutical legislation, including AMG, AMWHV, and EU GMP rules.
* Proven experience in a similar role within the pharmaceutical industry, with a focus on manufacturing and batch-release processes.
* Must have experience in a QP position.
* Demonstrated leadership skills with the ability to manage cross-functional teams and drive compliance initiatives.
* Exceptional organizational skills, with the ability to handle multiple priorities and work under pressure.
* Availability and flexibility to address quality and compliance issues..
* Fluent German and conversational English needed
Compensation + Benefits:
* Up to 250,000 Euros base depending on experience
* Bonus available
* Equity/Shares available.
* Company Car
* All Legal German Benefits
* Hybrid working model
How to Apply:
If this role sounds interesting, then please apply through this site or email me your CV at aj.mishra@luminorecruit.com. Referral fees are available