Our client is a biopharmaceutical company producing and developing novel drugs. The focus is on cancer immunotherapies and molecular therapies. Currently, the company is still in the clinical stage.
For the further development of the quality department on site, we are looking for a
Senior Director Quality IMPs (f/m/d)
Your Responsibilities:
1. Manage the manufacturing Quality Assurance area, ensuring GMP compliance and on-time manufacturing and release.
2. Take responsibility for the release of materials, products, API, and clinical test samples as a Qualified Person (in compliance with AMG Sec. 15 / EU GMP guidelines).
3. Lead the quality clinical trial material manufacturing functional area by example, and coach and develop direct reports (appraisals and qualification measures).
4. Be part of the Manufacturing Leadership Team and CV Quality Leadership team.
5. Act as the first contact for health authorities and inspections.
6. Coordinate and ensure continuous quality optimization of processes between production and clinic, incoming goods, quality control, technology, logistics, shipping, and quality management.
7. Develop and maintain effective partnering relationships with customers and stakeholders.
8. Take responsibility for budget planning.
Your Profile:
1. Advanced degree in natural science (e.g., biology, microbiology, chemistry), ideally PhD or an equivalent qualification.
2. Experience in QA leadership in the pharmaceutical industry and several years of management and professional experience in clinical trial QA.
3. Fulfillment of the requirements for a qualification as a Qualified Person (according to AMG Sec. 14 and 15).
4. Deep knowledge of and experience in pharmaceutical production and QA according to GMP standards and strong knowledge of GMP, GCP, GLP, and related processes.
5. Sound knowledge of legal and regulatory requirements, such as pharmaceutical law and the ICH guidelines, as well as basic knowledge of regulatory affairs.
6. Executive presence and leadership skills with prior outstanding team management experience.
7. Fluency in German and English, both written and spoken.
What You Can Expect:
1. A clinical stage biotech with state-of-the-art manufacturing facilities.
2. Be part of a pioneering German company.
3. A well-established team with experienced stakeholders.
Interested in this opportunity? If I have piqued your interest, please let me know when we can schedule a call to discuss further. I look forward to meeting you!
#J-18808-Ljbffr