(Senior) Manager (f/m/x) Clinical Quality Assurance

Quality Assurance & Regulatory Affairs | FUTRUE Gruppe | Gräfelfing

(Senior) Manager (f/m/x) Clinical Quality Assurance

Quality Assurance & Regulatory Affairs | FUTRUE Gruppe | Gräfelfing

Über uns / About us

FUTRUE is an internationally active healthcare incubator with more than 20 companies and more than 70 drug approvals, including in the areas of smart bacteria, innovative pain therapies, chemical-free drugs, medical cannabis and orphan diseases.
 
Our focus is on the identification of innovative and already well-developed compounds by means of our globally active scouts. After a status check of preclinical and clinical data using a proprietary algorithm, a highly standardized process starts to generate all outstanding data for a timely approval. Our own specialized marketing and sales teams ensure that information is provided to healthcare professionals and that patients are treated with the respective drug in a timely manner. 
 
Our claim is to be faster than any other pharmaceutical company - because our patients have no time! To achieve this, we are relying on a new generation of dynamic talents who have the courage to tread unfamiliar paths.

Deine Aufgaben / Your tasks

  • Contribute to the development, maintenance, and continuous improvement of the quality system processes including creation and review of GCP relevant SOPs.
  • Identify non-compliance trends and systematic risks for assigned areas of responsibility.
  • Support the conduct and follow-up of internal and external audits on Investigator Sites, CROs, supporting laboratories, and monitoring organizations.
  • Support Quality Management by facilitating regulatory agency inspections and related activities.
  • Support of the clinical operations team regarding GCP-relevant questions/topics.
  • Serve as the primary CQA contact for the assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/GCLP/GLP/GVP.
  • Support and lead inspection readiness activities resulting in successful agency (FDA, EMA) inspections.

Dein Profil / Your profile

  • BS/BA or MS/MA degree in medicine, sciences, pharmacy, biotechnology or equivalent.
  • Minimum of 2 years of experience in clinical research industry, at least 1 of which in QA
  • Good understanding of GCP guidelines, knowledge of QA processes and how to follow QA process guidelines, experience developing SOPs and Wis such as experience in internal and external audits
  • Detail orientation, with strong communication and organizational skills ad critical thinking mindset with a problem-solving ability
  • Capable of working with minimal supervision and the ability to efficiently organize, monitor, and complete tasks
  • Fluent English and German (verbal and written)

Unser Versprechen / Our promise

We offer you a diverse, challenging job with exciting tasks and a wide range of creative opportunities! Our innovative environment allows you to develop your career with short decision-making processes and the freedom to go new ways! Also waiting for you:

  • Flat hierarchies and open communication - this is the only way you can develop yourself and contribute to the fact that our products live from our mutual exchange.
  • Responsibility - after an induction phase with an experienced colleague or your team lead, you will be given the opportunity to take charge of your own area. Do you have the entrepreneurship in you? Then we can create great things together!
  • Fresh vitamins - weekly you will be provided with our fruit basket, which will give you the necessary energy.
  • Company parties are a matter of course for us - whether it's a summer party, the traditional Wiesn visit or the annual Christmas party.
  • A roof terrace with a panoramic view of the Alps - relax during your lunch break and soak up the sun in good weather.

Apply now! We look forward to getting to know you!




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Telefon: +49 (0) 89 78 7979 0 - 873
jobs@futrue.com


 

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