Quality Strategy Lead (all genders) Risk Management

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A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your Role:In your role you will be responsible for the rollout of the Quality Risk Management strategy to our global Healthcare Research and Development (R&D) organization. Based on the Quality Risk Management (QRM) framework you will support related activities in the different R&D functional units and thus foster a positive quality improvement culture. Your project management and communication skills combined with your data management and technical expertise will be essential for the operational implementation of the QRM across Healthcare R&D. You will work closely with R&D management and Quality Risk Management experts to manage identified risks within R&D as well as cross-functional risks in Healthcare. You will be part of the Quality Risk Management working group and report critical information to R&D management. The role willset-up and steer project plan as well as develop and implement a communication strategy to ensure successful rollout of the Quality Risk Management strategy. You will act as Subject Matter Expert support for the technical implementation of risk management functionalities in our electronic Quality Management System (eQMS/ Veeva Vault QMS). The role creates information and training material to support the operational implementation of the Quality Risk Management. It Supports identification and management of R&D Quality specific quality risks and support the RDQ Quality Strategy Leads in risk-based identification and selection of audit entities (vendors, processes, subsidiaries, business partners, programs, and trials)

Who you are:

  • Bachelor or Master degree in scientific or quality management subject; equivalent relevant quality-related working experience may be considered
  • Proven track record in project management and change management; strong communication and implementation skills
  • Experience working with electronic Quality Management Systems (preferably Veeva Vault QMS) or Risk Management Systems
  • Knowledge of drug development process, especially in clinical development (QbD, CtQ, QTL, RBM), data analytics (QTL, RBM), international GCP regulations as well as pharmacovigilance guidelines
  • Knowledge in quality risk management (ISO 31000, ICH Q9 Pharmacovigilance, TransCelerate) and methods for risk analysis (fault-tree analysis, FMEA, Ishikawa, etc.)
  • Strong critical thinking skills to analyze complex situations and discern critical issues
  • Proven ability to work independently at senior level in a matrix organization as well as working in a team.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Art des Stellenangebotes:


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