GREX-0, Quality Strategy Lead CS

 

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.
• Comprehensively demonstrated working knowledge of principles and concepts of project management, computerized system validation principles, data integrity, and the concept of Quality Assurance, including those related to SDLC.
• Extensive knowledge of IT quality requirements in pharmaceutical industry, with focus on non-clinical, clinical and pharmacovigilance areas, validation, cloud computing, business continuity, PaaS, SaaS and laaS.
• Comprehensive working knowledge of the end-to-end IT development lifecycle model and IT infrastructure and the respective regulations/guidelines (GAMP, PIC, ITIL, OECD, 21 CFR part 11).
• Broad working knowledge of GCP, GLP and GVP and expertise in continuous improvement e.g. metrics, Lean Six Sigma.
• Broad understanding of the drug development processes and related regulatory environment.
• Project Management certification is a plus.
• Proven ability to function autonomously at a senior level in a matrix model and in a team environment.
• Demonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem-solving capabilities.
• Demonstrated ability to work independently and manage time efficiently and effective
• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective
• Fluency in English (oral and written)

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

 

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!