Organon - Research & Development Regional Quality Assurance Lead - Executive Director ( MERCUSR80787ENUS)
The purpose of the Research & Development Regional Quality Assurance Lead in Research & Development is to lead and provide end to end quality and compliance strategies Globally and across partnerships. The R&D Quality Assurance Lead serves as a designated point of contact for R&D functions related to GCP, GVP, GLP and Company compliance related activities, ensuring regional/country pathways for support through assigned team members. The Lead provides overall R&D quality assurance support in line with the execution of global quality processes, ensuring local and regional attributes are suitable against both global & local requirements. The Lead is responsible for ensuring key quality principles are considered and incorporated when designing new programs, risk mitigation strategies for programs underway and utilization of process metrics to inform the state of quality across business process execution. As a member of the R&D Quality Leadership team, the Lead is responsible and accountable to make quality an enabler to the business and partner of choice. The Lead will work collaboratively to support the build and optimization of the R&D QMS; activities include quality issue management advice, inspection strategy and support, and a key advisor on process excellence and development activities. Through a principles-based quality approach, the Lead enables the business to uphold the rights and welfare of patients and trial participants, strive for data integrity in support of critical business and regulatory decision making and anchor in commitment to scientific integrity, driving quality proactively.
- Reports to Head, Research & Development QA
- Member of the Research & Development QA Leadership Team
- Partners with other Research & Development QA Leads to assure consistent professional and appropriate Research & Development QA support and cross portfolio quality oversight
- Works with all relevant local global Research & Development Division's R & D staff (and other contacts including Human Health, Commercial and Manufacturing Compliance functions)
- Works with external contacts including Regulatory authorities as it applies to inspection activities, professional scientific groups and consultants as well as outsourced providers of QA services
- Works with the business to ensure appropriate and proportionate approach to quality and compliance issues and challenges
- As a member of the Research & Development QA LT, champions the QA mission and sets Research & Development QA policies and long- term strategies. In collaboration with other R&D sub-functions, the Lead develops strategies to promote successful health authority inspections and submission approval outcomes.
- The Research & Development QA Regional Lead effectively engages teams and has proven ability to represent Research & Development QA aligned strategies and processes. The role will deliver critical expertise to the Research & Development QA LT, organization, customers and stakeholders via quality audit processes, systems, and responsibilities. The Research & Development QA Regional Lead will conduct timely and efficient internal communication of resource and data quality matters.
- The Research & Development QA Regional Lead demonstrates capacity to advise teams and individuals, including mentoring and coaching colleagues, as needed.
- The Research & Development QA Regional Lead will be responsible for staff and talent management development, including performance management.
- The Research & Development QA Regional Lead will maintain a current knowledge of industry quality trends is needed along with capacity to continue to build quality knowledge internally and externally. May assume responsibility for other activities/functions within Research & Development QA as required.
- Required: Bachelor’s degree or equivalent experience
- Preferred: Advanced academic qualification/degree
- Equivalent relevant professional experience will be considered.
- 15+ years R&D oversight experience or relevant experience in clinical/regulatory/medical affairs quality management, biomedical science, clinical development, or regulatory strategy; equivalent experience
- 5 + years’ experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
- Demonstrated teaching and coaching capabilities and experience as a manager of people
- Proven ability to function autonomously at a senior level in a matrix model and in a team environment
- Proven business management capability
- Proven ability to think creatively and to develop and execute strategic plans
- Travel Required: up to 30%
- Demonstrated knowledge of ICH GCP, GLP, GPvP, clinical development and principles of quality assurance
- Uses rigorous logic and methods to solve difficult problems with effective solutions.
- Probes all sources for answers; can identify hidden problems
- Is excellent at analysis
- Goes beyond the obvious and seeks novel approaches to complex issues
- Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats
- Considers customers, including regulatory agencies, clinical and safety, in developing strategies, risk priorities and future direction
- Is credible, with proven leadership skills to develop and grow next generation of Research & Development QA professionals
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