Rdq Quality Strategy Lead Development

vor 4 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**:
***
The RDQ Quality Strategy Lead (all genders) Development will be mainly responsible for managing the program day to day activities from quality 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 strategy in support of the program and to utilize/develop RDQ tools to deliver the strategy.

Provides input in the global Development audit plans based on identified signals /trends/ risks / gaps.
- May influence the external environment through interactions with regulators, trade associations, or professional societies.
- Proactively identifies risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs.
- Provides RDQ expertise during due diligence process.
- Ensures rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/program/ studies/ products, to business partners and senior management.
- Leads, provides guidance and tools for ensuring inspection preparation to teams/business partners.
- Actively supports the study team with the preparation, the execution, follow up and close out of relevant health authority inspections within the area of responsibility.
- Advises internal customers, as well as functional lines, and stakeholders on how to address study or process issues while maintaining compliance with worldwide regulations, guidelines, and Merck SOPs.
- Decisions often impact own work as well as that of RDQ/internal customers/regional and functional lines.
- Leads multidisciplinary or cross-functional work/project teams; serves as part of strategic team(s) within the group/discipline. Actively shares knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems. Strong technical expertise - leads complex projects, coaches and mentors others and is recognized within RDQ and outside RDQ as a technical specialist
- Communication with relevant R&D partners (eg. SBDO, CMO, Biostatics, Clinical Development, GPT, GPS) and within RDQ.
- Monitor and report relevant quality information to relevant R&D partners
- Works closely with other RDQ functional leaders through matrix management principles (not structure)

**KEY TASKS & RESPONSIBILITIES**
- Provides day to day RDQ support to the assigned program/ studies
- Contributes to RDQ strategy and implementation to support goals of the Development Unit or program team
- Is accountable for the RDQ strategy of the assigned program
- Monitors and reviews program audit activities, ensures consistency in approach and reporting and tracks deliverables against the audit schedule
- Develops and enhances RDQ procedures, guidance documents and audit tools covering program audits and identifies opportunities and proposal for clinical trial oversight improvement
- Provides GCP expertise and quality assurance expertise within the program
- Performs ongoing quality risk-assessment and evaluation of the program
- Defines, implements, monitors and manages the strategic compound plan
- Manages deviations in the area of responsibility
- Ensure targeted inspection preparation in the area of responsibility and implements required activities.
- Ensure rapid communication and management of R&D issues, including potential misconduct or issues of significant deviations with projects/product, to appropriate leaders and colleagues.
- Participate in preparation, execution and close out of health authority inspection in collaboration with the Inspection Management Lead
- Participate in special assignments on various project teams and workstreams as determined by RDQ management.
- Knows and keeps up to date with the developments in the disease area of responsibility and status of competitor products
- Actively mo

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