Team Lead / Director (f/m/x) Clinical Quality Assurance

Quality Assurance & Regulatory Affairs | FUTRUE Gruppe | Gräfelfing

Team Lead / Director (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

  • Assures quality and regulatory compliance related to GCPs, GVP, GLPs, and other related activities performed by clinical department.
  • Provide strategic direction with cross functional working groups to identify and mitigate quality and compliance issues.
  • Prepare clinical audit plans and conduct internal and external audits on Investigator Sites, CROs, supporting laboratories, and monitoring organizations, generating audit reports and communicating findings to relevant stakeholders in a manner that ensures corrective and preventative actions are systemic and durable.
  • Participate in preparations for regulatory inspections and act as company’s representative for clinical QA during regulatory agency inspections.
  • Collaborate with functional teams to provide Quality guidance and assistance with development of documents and processes using risk management principles.
  • Manage the GCP training program and provide training as required including the annual GCP training.
  • Determine the strategy for and lead the implementation of inspection readiness plans and activities.

Dein Profil / Your profile

  • BS/BA or MS/MA degree in medicine, sciences, pharmacy, biotechnology or equivalent.
  • Minimum of 5 years of experience in clinical research industry, at least 3 of which are in QA
  • Full understanding of ICH/EMA/FDA GCP guidelines, with a working knowledge of cGMP, GCLP, GLP, and PVs such as experience with Phase I to III clinical trails
  • and developing SOPs and WIs, reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in current SOPs and the ability to independently conduct internal and external audits, author audit reports, manage CAPA process
  • Excellent attention to detail and a strong leadership, communication, and project management skills in a cross functional team such as quick in understanding difficult and complex situations, anticipates potential issues, acts quickly / proactively and resolves them effectively
  • 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!
  • Flexible working - our teams work proportionally from the home office and on site, so you can organize your working day independently and individually.
  • 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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