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 more than an internationally oriented healthcare group! With over 20 companies and more than 70 drug approvals, we are a global leader in the fields of intelligent bacteria, innovative pain therapies and chemical-free drugs. Many of our companies, including e.g. SYNformulas or Vertanical, are among the fastest growing healthcare companies. To continue this success, we are relying on a new generation of dynamic talents who have the courage to explore unfamiliar paths.

Due to our dynamic growth as well as the continuous expansion of our product portfolio, we are looking for motivated and dedicated talents to join our successful teams. Our goal is to give as many people as possible a better life.

Do you want to help shape the future? Then apply now!

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 make things happen - and fast! You can expect a top management board of high-class entrepreneurs, former consultants and experienced industry greats. We offer you the environment in which you can develop personally and professionally in an unprecedented way.

Bewirb Dich jetzt! Wir freuen uns darauf, Dich kennenzulernen! / Apply now! We look forward to getting to know you!

 

mit * gekennzeichnete Felder sind Pflichtfelder / * marked fields are mandatory



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


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