RDQ Quality Strategy Lead (all genders) Development
The RDQ Quality Strategy Lead (all genders) Development will be mainly responsible for managing clinical programs day to day activities from quality assurance perspective and delivering the full range of quality related activities in support of the program.
The incumbent works closely with the project / program teams and is accountable for establishing the quality assurance strategy in support of the program and to utilize / develop RDQ tools to deliver the strategy.
You will lead multidisciplinary or cross-functional work / project teams and actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.
You will be responsible to lead inspection preparedness activities in the cross-functional teams and partners for assigned trials / programs as part of the planned regulatory submission in different Countries / authorities (China, EU, US, Japan, etc).
Strong technical expertise is a must as you will additionally lead complex projects, involve in due diligence (DD) as quality expert, and coach and mentor other colleagues in our field of Research & Development (R&D).
Who you are : Bachelor's degree in a relevant scientific field; advanced degree preferred.Minimum of 10 years of experience in quality assurance within the pharmaceutical or healthcare industry with focus on ICH GCP.
Experience in medical device clinical trials is a plus.Experience in leading inspection readiness or inspection preparation activities.
Experience in inspection management and response is a plus.Knowledge / experience of due diligence processes related to asset transfer, in / out licensing, and business development preferred.
Proven analytical skills with a keen interest in data analysis and interpretation.Agile, adaptable, and curious mindset with a commitment to driving quality excellence.
Proven ability to function autonomously at a senior level in a matrix model and in a team environmentFluent in written and spoken English Position can be located in all EU countries
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