Quality Strategy Lead Data Lifecycle Management

vor 6 Monaten

Darmstadt, Deutschland Merck KGaA Darmstadt Germany Vollzeit

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**:
In your role you will be responsible for compliance oversight of the R&D Data Lifecycle Management in our global Healthcare Research and Development (R&D) organization.

Based on the R&D Data Integrity framework you will support related activities in the different R&D functional units and thus foster a positive and proactive compliant data management culture. Your project management and communication skills combined with your data management and technical expertise will be essential for the operational implementation of the data integrity strategy and process across Healthcare R&D. You will work closely with R&D management and data management experts to ensure that data is created, managed, transferred, and archived following GxP regulations within R&D. With information gained from audits, inspections, collaborative discussions, trends / metrics, and root cause analysis you will identify and drive continuous quality process improvements. In this role you will ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products related to the data lifecycle, to business partners and senior management. You will be part of the cross functional Merck Data Integrity Community of Practice and report critical information to R&D management. The role creates information and training material and provides guidance and training on relevant GxP regulations and guidelines to cross functional business partners.

**Who you are:
- Bachelor's or master's degree in computer science, natural science, or life science (relevant professional experience might be taken into consideration)
- Experience in supporting cross-functional process or system improvement projects
- Strong quality mindset, understanding of quality oversight & associated metrics as well as in depth knowledge of applicable worldwide regulations, especially in Data Integrity, new technologies & Computerized Systems and ICH guidelines
- Broad knowledge/expertise in quality management system and continuous improvement with background in appropriate tools/procedure e.g. Inspection Readiness, Deviations, Corrective and Preventive Actions, Root Cause Analysis, Audits, Vendor Management, Computerized System Validation and Risk Management. Lean Six Sigma training is a plus.
- Knowledge of drug development process, especially in clinical development, international GCP regulations
- Experience in developing, delivering, and implementing comprehensive training curricula
- Strong critical thinking skills to analyze complex situations and discern critical issues
- Proven ability to work independently in a matrix organization as well as working in a team, and building and maintaining cross-functional networks/collaborative partnerships

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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

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