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Quality and Governance Compliance Management

Há 1 mês

São Paulo, Brasil F. Hoffmann-La Roche Gruppe Tempo inteiro

Roche fördert Diversität, Gleichstellung und Inklusion und repräsentiert die Gemeinschaften, denen wir dienen. Wenn es um die Gesundheitsversorgung auf globaler Ebene geht, ist Vielfalt eine wesentliche Zutat für den Erfolg. Wir glauben, dass Inklusion der Schlüssel zum Verständnis der unterschiedlichen Bedürfnisse der Menschen im Gesundheitsbereich ist. Gemeinsam engagieren wir uns für Individualität und teilen die Leidenschaft für eine herausragende Versorgung. Kommen Sie zu Roche, wo jede Stimme zählt.

Die Position

A healthier future. That’s what motivates us to innovate. Continuously promote science and ensure that everyone has access to the health care they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

As a Medical Quality and Governance Compliance Management, you will be the focal point of Roche responsible to manage the coordination and preparation of GCP/GVP audits, inspections and compliance in accordance with regulatory standards, map, assess and manage medical compliance risks, training compliance, improvement management, service provider management and oversight process related to GCP/GVP and scientific credibility, publication and external communication material.

About the opportunity:

  • Coordinate and prepare GCP/GVP audits, inspections and compliance in accordance with regulatory standards, map, assess and manage medical compliance risks, training compliance, improvement management, service provider management and oversight process.
  • Responsible for evolving affiliate maturity of scientific credibility, publication, local process of external material exposition governance, other areas training and monitoring.
  • Develops positive and proactive approaches to medical compliance.
  • Lead good clinical and pharmacovigilance practices training of functional areas and assists in the development of training sessions.
  • Oversees all interactions during regulatory agency inspections and manages interaction with regulatory agencies on defined matters.
  • Provides guidance on interpretation and application of GCP/GVP/IVD/Medical Device and Digital Health regulations.
  • May also perform audits and self-inspection, coordinate audit follow-up and corrective action planning and evaluate employees to ensure the efficient operation of the function. Act as a VACC leader.

Qualification:

  • Bachelor degree in Pharmacy, Biomedicine or other health related areas.
  • Advanced English.
  • Previous experience in Medical Quality, Compliance, Clinical Operations/Trials, Pharmacovigilance, Market Research and Patient Support Program, RWE/D research conduction.
  • Deep knowledge of process improvement, quality (GCP/GVP preferred), lean, medical device, scientific credibility and local regulation related to these topics.
  • Previous experience in Multinational pharmaceutical Company with global projects.
  • Availability to work in São Paulo.
Wer wir sind

Bei Roche leisten 100,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

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