Organon - Executive Director, Research and Development Quality Data Integrity, Analytics and Digital ( MERCUSR102971ENUS)
The purpose of the Research & Development (R&D) Quality Lead for Data Integrity, Analytics and Digital is to lead and provide end to end quality and compliance strategies Globally and across partnerships with a focus on maintaining quality throughout. This Lead serves as a designated point of contact for R&D functions in regards to Data integrity across GXP as well as compliance requirements to GXP related technologies and use of digital and alternative data capture techniques.
Providing support globally through partnering with regional partners as well as with outsourced partners. The Lead provides overall quality assurance support in line with the execution of global quality processes with an eye toward maintaining quality and compliance, while utilizing technology to optimize process execution across the business, ensuring local and regional attributes are suitable against both global & local requirements. Responsible for engaging with process owners and driving the use of thresholds and key quality or process indicators to drive process oversight enabling a focus for quality on meaningful avoidance of key risks associated with rights and welfare of patients and trial participants, the data integrity in support of critical business and regulatory decision making and to scientific integrity.
As a member of the R&D Quality Leadership team, responsible and accountable to make quality an enabler to the business and for quality to be partner of choice. Working collaboratively with Quality peers across the enterprise to build support the build and optimization of the R&D QMS. Ability to apply a principles based quality approach, enable the business to uphold the rights and welfare of patients and trial participants, drive for data integrity in support of critical business and regulatory decision making and anchor in commitment to scientific integrity, and driving quality proactively.
- As a member of the Research & Development QA Leadership Team (LT), champions the QA mission and sets Research & Development QA policies and long- term strategies in assigned areas.
- The Executive Director, R&D Quality Data Integrity, Analytics and Digital 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 Executive Director, R&D Quality Data Integrity, Analytics and Digital will conduct timely and efficient internal communication of resource and data quality matters.
- The incumbent demonstrates capacity to advise teams and individuals, including mentoring and coaching colleagues, as needed.
- The incumbent will be responsible for staff and talent management development, including performance management.
- The Incumbent 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.
- A minimum of fifteen (15) years R&D oversight experience or relevant experience in safety/clinical/regulatory/medical affairs quality management, biomedical science, clinical development, or regulatory strategy; equivalent experience
- A minimum of five (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 problem and 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
Who we are …
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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