A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Quality Strategy Lead Data Integrity is responsible for providing oversight of an effective and knowledgeable GxP Data Integrity Governance program across end-to-end (R&D) product life cycle to ensure that regulatory and Merck requirements are addressed thoroughly and effectively in a timely manner. The incumbent will be direct, develop and maintain the quality strategy for data integrity, identify areas of risks and drive the respective mitigation activities and support the various audit and QRM programs across and within departments around data integrity concepts.
Who you are:
* Bachelor in Computer Science, Life Science or quality related subject required. Advanced degree desirable. Equivalent relevant experience maybe considered.
* Mimimum 10 years experience in pharmaceutical and/or biotech industry, inparticular quality assurance, quality management, clinical development, biomedical science or information technology.
* In depth knowledge of GxPs and ERES (21 CFR part 11 and Annex 11) and Data Integrity (including but not limited to WHO, MHRA, FDA) regulatory requirements and data governance principles
* Strong critical thinking to analyze complex situations and discern critical issues
* Must understand industry accepted software development and validation life cycle programs (GAMP5)
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!
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