Head Training Quality Compliance (m/f/d)

Einsatzort: Nürnberg

Novartis Pharma GmbH

927 million. That's how many lives our products touched in 2018.

And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Within this innovative environment we are currently hiring a

Head Training Quality Compliance (m/f/d)

Your responsibilities:

  • Accountability for planning, managing and delivering country level activities with regard to quality and training matters to assure high quality trial execution of Phase I-IV Oncology and Pharma clinical trials
  • Partnering with the Global Training Network to implement the Trial Monitoring Organisation (TMO) training strategy and to align on TMO specific training needs
  • Formulation of a strategy in collaboration with Trial Monitoring Country Head, Country Chief Scientific Officer / Medical Director and global stakeholders to assure high quality across study portfolio
  • Leading, developing, coaching of employees and planning of resources
  • Performing quality assessments as well as understanding quality issues in order to initiate adequate actions in close collaboration with Development Units and Quality Assurance (QA)
  • Responsibility for budget oversight and management
  • Supervision of Quality & Training procedures
  • Implementation and definition of global TMO CPO associates training strategy in close alignment with Global Network Training
  • Ensuring that quality issues are escalated, tracked and trended within TMO
  • Implementation and definition of quality measures in close cooperation with Development Units and global stakeholders
  • Identifying training need within TMO and providing adequate training for onboarding and continuous education of TMO members

What do we expect?

  • A degree in Natural or Medical Sciences
  • At least 8 years of experience in clinical research, in planning/executing and/or monitoring clinical trials with a minimum of 2 years in a people management role
  • Excellent understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
  • Strong capability in working in a globally / country matrixed environment
  • Thorough understanding of the international aspects of the drug development process including expert knowledge of international standards (ICH-GCP), health authorities (FDA / EMEA), local Health Authority regulations and Novartis standards
  • Established track record of leading successful teams, preferably with experience in working with international teams
  • Proven strong leadership skills, strategic thinking skills and matrix management skills paired with strong interpersonal, negotiation and conflict resolution skills and fluency regarding German and English language skills

What you can count on?

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples' lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

We are looking forward to receiving your detailed application at: www.karriere.novartis.de

StellenID: 260410BR

Leiter Leitung Sicherung der Versuchsqualität Klinische Forschung Klinisches Versuchswesen Qualitätswesen Qualitätssicherung GMP GCP Good Clinical Practice Versuchsplanung Versuchsmonitoring Versuchsqualität Testwesen Testqualität Mitarbeiterschulung Betriebsinternes Schulungswesen Professional Training Arzneimittelentwicklung Arzneimittelzulassung Arzneimittelunbedenklichkeit Medikamentenprüfung Wirksamkeitsprüfung Wirksamkeitsnachweis Pharmakovigilanz Arzneimittelsicherheit Regelkonformität Pharmazeutische Qualität Randomisierte kontrollierte Studien RCT Zentralisiertes Verfahren GCP-Verordnung Naturwissenschaftler Biologe Biochemiker Pharmakologe Chemiker Mediziner Physiologe Life Sciences Mitarbeiterführung Mitarbeiterentwicklung Budgetkontrolle Leitungsfunktion Führungsposition Bayern Nürnberg Novartis Pharma GmbH ax82976by