Technical Director (m/w/d)
Technical Director (m/w/d)Location: Frankfurt am Main, Niederrad, DE Contract Type: Regular Full-Time Area: Quality Req Id: 547384 Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment. The focus of the Technical Director role is to provide strategic leadership across Quality and Regulatory Affairs for our German affiliate, ensuring compliance with applicable regulations while supporting business growth, patient safety and operational excellence. As a key member of the organization, you will act as the senior representative for Quality and Regulatory matters, partnering with both local and global stakeholders. What your main responsibilities will be You will have the opportunity to:
- Lead the Quality and Regulatory functions for the affiliate, ensuring compliance with applicable regulations, corporate standards and Health Authority requirements.
- Drive the effectiveness and continuous improvement of the Quality Management System (QMS), providing oversight of quality processes, audits, supplier management and GDP activities.
- In coordination with the Global Regulatory Affairs Department, contribute to the definition and execution of regulatory strategy, ensuring the timely and compliant submission of regulatory affairs.
- Represent Grifols before Health Authorities, leading interactions, inspections, audits and significant regulatory discussions.
- Collaborate closely with Commercial, Supply Chain, Pharmacovigilance, Medical Affairs and Corporate functions to support business objectives while maintaining the highest standards of quality and compliance.
- Promote a culture of quality, integrity, patient safety and continuous improvement across the organization.
- Act as the affiliate's primary representative towards Health Authorities, leading inspections, audits, product recalls and critical regulatory interactions.
- Lead local product recall activities and ensure effective risk-based decision making to protect patient safety and business continuity.
- Ensure compliance for medicinal products, medical devices and in-vitro diagnostic products.
- Degree in Pharmacy or another relevant scientific discipline in accordance with local regulatory requirements.
- Extensive experience in Quality Assurance, Regulatory Affairs, Technical Operations or related functions within the pharmaceutical, biotechnology, medical device or healthcare industry.
- Proven experience leading Quality Management Systems and working within highly regulated environments.
- Strong knowledge of regulatory requirements, product lifecycle management and Health Authority interactions.
- Demonstrated leadership experience with the ability to influence cross-functional stakeholders and drive strategic decisions.
- Experience leading or supporting inspections, audits and compliance-related activities.
- Strong communication, negotiation and stakeholder management skills.
- Ability to make independent, risk-based decisions in complex compliance situations.
- Fluent German and English.
- Competitive benefits package.
- Permanent employment contract.
- Exposure to local, regional and global stakeholders.
- Opportunity to influence strategic decisions within a highly regulated healthcare environment.
- Professional development within a multinational organization.
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