Director of Quality & Regulatory Affairs.
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, one of the world's largest in the medical cannabis sector, employs over 500 people globally. In Germany, our client has a dedicated team of over 100 employees, with 50 in the Quality/RA department that you would be leading. You will report to the Managing Director in Germany.
Job Summary:
The Director of Quality & Regulatory Affairs is a senior leadership position responsible for overseeing all quality assurance, quality control, and regulatory affairs activities for the client in Germany. This role ensures that the company complies with all applicable pharmaceutical regulations, maintains the highest standards of quality, and successfully navigates the complex regulatory landscape. The Director will lead a team of 50 Quality & RA professionals and collaborate with other departments to support the company’s strategic objectives.
Key Responsibilities:
* Regulatory Compliance: Ensure compliance with all relevant pharmaceutical regulations across the company’s operations, including manufacturing, testing, packaging, and distribution.
* Quality Management System (QMS): Oversee the development, implementation, and maintenance of the Quality Management System, ensuring alignment with GMP guidelines and GDP regulatory requirements.
* Supplier and Contractor Management: Lead the selection, qualification, and ongoing monitoring of suppliers, contract manufacturers, and freight forwarders. This includes conducting audits, reviewing documents, and approving contracts.
* Self-Inspections and Audits: Organize and oversee internal self-inspections, as well as prepare for and manage external audits and inspections by regulatory authorities.
* Regulatory Affairs: Ensure timely and accurate submission of all regulatory filings and maintain effective communication with regulatory authorities. Provide strategic guidance on regulatory matters and stay informed about changes in regulations.
* SOP Review and Approval: Oversee the review and approval of all GMP-relevant Standard Operating Procedures (SOPs), ensuring they reflect current regulations and best practices.
* Deviation and Complaint Management: Lead the review and resolution of deviations, pharmaceutical-technical complaints, and other quality issues. Implement corrective and preventive actions (CAPAs) as necessary.
* Product Quality Reviews and Documentation: Ensure the preparation and evaluation of product quality reviews, Site master files, and other key quality documents.
* Team Leadership: Manage and mentor the Quality & Regulatory Affairs team, fostering a culture of continuous improvement, compliance, and professional development.
* Strategic Advising: Advise senior management on quality and regulatory strategies, ensuring that all operations align with the company’s goals and regulatory obligations.
* Stakeholder Communication: Act as the primary point of contact for quality-related inquiries, both internally and externally. Represent the company in regulatory discussions and during inspections.
* Collaboration: Work closely with other departments such as Production, R&D, and Supply Chain to ensure that quality and regulatory requirements are integrated into all aspects of the business.
Qualifications and Experience:
* Experience: A minimum of 7 years of experience in the pharmaceutical industry, with at least 3-5 years in a senior quality or regulatory affairs managment role, or similar role.
* Knowledge: Comprehensive understanding of EU GMP guidelines, regulatory
* requirements, and pharmaceutical manufacturing processes. Experience in managing regulatory submissions and audits. Knowledge of GDP would be a bonus.
* Leadership Skills: Proven leadership experience, with the ability to manage and develop a high-performing team.
* Analytical and Problem-Solving Skills: Strong ability to analyze complex situations, identify risks, and implement effective solutions.
* Languages: Fluency in German and conversational English is required.
Compensation + Benefits:
* 130,000 - 200,000 Euros base depending on experience
* Company Car
* Bonus Available
* Equity/Shares available
* 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.
Note: Applicants must be based in Germany and have the right to work in the EU.