Quality Director Qualified Person/Sachkundige Person
Location: Frankfurt
Reports to: Quality Head
The Company
One of the world’s most innovative biotechnology companies are continuing their global expansion across Europe, North America, Africa, and the Asia Pacific (APAC). Due to this, their post-market surveillance phase of the organization is exploding to deliver essential medicines in their development of immune-therapies to patients across the globe. Combining ground-breaking research, cutting edge technology, and pioneering immunotherapies, they are aiming to become the worlds leading biotechnology company.
The Role
As the Quality Director Qualified Person/Sachkundige Person, you will be a critical part of the project to spear-head their capability to ensure life-saving medicines manufactured in Germany comply to international FDA, EMA, and local Health Authority Quality guidelines. Your role as the Quality Director Qualified Person/Sachkundige Person is to also ensure that these pioneering and state-of-the-art medicines fully adhere to international Good Manufacturing Practice (GMP) and are therefore safe for the patients to use in their fight against disease.
As the Quality Director Qualified Person/Sachkundige Person, you will be responsible for the release of active ingredients and approved medicinal products.
Responsibilities
* Ensuring the Quality of each batch release of manufactured products
* Qualified Person/ Sachkundige Person topics for batch release
* Contribute to self-inspections for Quality standards
* Quality review of manufactured products
* Participate in Health Authority audits & inspections
* Monitoring of external suppliers/third parties
Requirements
* Registered or eligible to be a Qualified Person in Germany according to German Drug Law AMG 15.3
* Extensive experience in GMP standards for vaccines/ATMPs
* Audit experience with Health Authorities
* Extensive Quality Assurance experience
* Fluent in German& English language, written and oral
* Pharmacist
Benefits
* €100,000 - €150,000 basic annual salary (depending on experience, could consider higher)
* Relocation support
* Company Pension
* Childcare Allowance
* Private Pension
Applications are to be sent to Matthew Lancaster along with a motivational letter and your availability for an initial screening call. Only selected applicants will be invited to an initial screening call.
To apply, email; matt.lancaster@discoverinternational.com