Our client is the largest biopharmaceutical company in Bavaria, with products across various indications. We are looking for a Director QA - Release (m/f/d) to optimize and structure the quality capacities as soon as possible.
A new production line with an investment volume of more than 500 million euros will be built at the site near Munich over the next five years.
Your Responsibilities:
1. Lead the team of Qualified Persons responsible for clinical trial materials and commercial products within the corporation.
2. Ensure the team has the necessary resources to approve clinical trial materials and commercial products.
3. Manage, motivate, develop, and evaluate team members.
4. Support Qualified Persons with strategic and operational issues.
5. Make decisions on the strategic direction of the team and their areas of responsibility, and assist in creating QAA and QP to QP agreements.
6. Organize, optimize, and improve processes related to the approval of clinical trial materials and commercial products.
7. Participate in global QA working teams.
8. Represent the team’s interests to internal departments, external partners, and authorities.
Your Profile:
1. Pharmacy degree with certification as a pharmacist and proof of expertise as per § 15 Abs. 1 AMG.
2. Required reliability for the role, demonstrated by a police clearance certificate.
3. Several years of experience as a Qualified Person, preferably with biotech drugs.
4. At least 10 years of leadership experience.
5. Independent and structured working style with high initiative and willingness to take responsibility.
6. Excellent English skills and intercultural competence.
What You Can Expect:
1. A new construction project in the three-digit million range.
2. Be part of one of the most modern production facilities in Europe.
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!
Your contact person is Maximilian Rudek.
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