Quality Strategy Lead Computerized Systems

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

YOUR ROLE

Quality Strategy Lead Computerized Systems, as part of R&D Quality Risk Management (RDQRM) team, is responsible for ensuring the integrity and compliance of quality management systems associated with R&D computerized systems (CS) and Artificial Intelligence (AI) technologies. Activities include developing CS Validation governance, as well as leading continuous improvement and preventive activities.

In this role you will create, establish and maintain a GLP, GCP and GVP compliant, efficient and global Computerized System Lifecycle approach (R&D IT SDLC) including a Risk based approach for Validation of GxP systems and qualification/audit of IT Vendors; Oversee electronic data integrity; Provide consultative Quality support regarding IT related topics to R&D functions and where appropriate to external industry and regulatory partners; Ensure, control and oversee the Computerized Systems validation process implementation and validation status maintenance; Represent the R&D and RDQRM at different IT governance meetings and projects; Contributes to setting of operational QA strategies, policies and direction for RDQRM; Provides input into the global audit plans based on risks identified for computerized system and IT vendor audits.

Who you are

• Minimum 10 years' experience in drug development, regulatory compliance or IT functions as well as a minimum of 5 years in Research, Development or IT Quality.