A career at Merck is an ongoing journey of discovery: our 50,000 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.
For the Global CMC, Regulatory Compliance organization within Merck Biopharma Quality we are looking for an experienced Portfolio and Strategic Project Manager / Director (m/f). Main responsibilities are Portfolio Management/Planning, fostering the Project Management approach in CMC Regulatory Compliance and the leadership of strategic initiatives.
The Portfolio Management includes KPI tracking as well as developing and maintaining the CMC regulatory compliance portfolio overview (e.g. dossier creation and compliance activities). You have to provide visibility of projects and the book of work according to prioritization. Additionally, you should define and continuously optimize planning process together with the interfaces (within Quality, Manufacturing, R&D and the Business Franchises). Driving digitalization of the portfolio process and reporting structures are also within your responsibility.
The Project management for CMC regulatory compliance with the development of standardized tools, templates and methodologies to support CMC regulatory compliance activities are your daily business.
Your role in leading cross-functional strategic Initiatives are driving organizational efficiency evaluations in CMC regulatory compliance and at the interface and to develop recommendations/options for improvements. You will define and formulate implementation plans; implement and track progress of and efficiency gains and support MBQ strategic initiatives e.g. lead work streams.
Who you are:
- Degree in a Life Science or related discipline such as pharmacy, biochemistry, chemistry or other relevant (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
- Project Management education and training (PMP or relevant project management certification a plus)
- Additional qualification in regulatory science and lean six sigma are a plus
- Min 7 years’ experience in the bio-pharma industry, 3 years’ experience in project management, CMC regulatory/compliance
- Demonstrated ability to implement systems and processes in a multisite environment
What we offer: At Merck, 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 come2merck.com