Director, Business Continuity Planning - REMOTE
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
The purpose of the Director, Business Continuity Planning (BCP) is ensure operational resiliency so the R&D organization can continue to carry out its mission in the presence of operational stress and disruption to achieve continuous functionality. The incumbent will develop the scope and context define the risks and business impact and design the strategy, creation, implementation, maintenance, and change (as needed) of Business Continuity Plans across all functional areas of R&D. The Director, BCP will recruit functional area expertise, coordinate the drafting, maintenance, and testing of BCP across all functional areas within R&D. In addition to testing Organon Research & Development (ORD) BCP via mock disaster using tabletop exercises, the Director will be responsible for documentation, tracking and leading functions in this space should a real emergency occur. Implementing standards to ensure strong oversight is critical including evaluation technology options and industry standards in the external environment with BCP experts. The incumbent will develop ongoing metrics that identify KPIs of the program to measure and ensure success.
The Director, BCP will assist the Executive Director, R&D Quality IT and Complex Systems as requested. The Director, BCP will assist the VP, Quality, Systems, and Sourcing with Crisis Management activities as needed. Reports to Executive Director, R&D Quality IT and Complex Systems. Partners with other Organon Functional area subject matter experts and BCP Leads to assure consistent professional standards. Works with all relevant local and global R&D leaders. Works with external contacts including Regulatory authorities (if necessary) as it applies to inspection activities, professional scientific groups, and consultants. Works with appropriate R&D functional areas to ensure appropriate, consistent, and proportionate approach to BCP activities, including any quality and compliance issues and challenges.
The scope of this position is global and across partnerships. This position serves as a designated point of contact for all R&D functions related to the R&D Business Continuity Plans including strategic intent for scope and overseeing initial creation of Business Continuity Plans, maintenance, testing, and reporting, and ensuring regional/country pathways for BCP support. The position provides overall R&D quality support in line with the execution of global BCP quality processes and compliance requirements, while ensuring local and regional data privacy regulations are followed and consistent with global policies and procedures. Travel Required: up to 10%
**This role can be 100% remote**
Responsible for leading the creation of functional BCPs, maintenance/update, and testing these plans on a regular basis via tabletop exercises or similar methods. This also includes the mock testing and evaluation of Crisis Management procedures and strategies.
Manage the employment of these systems directed towards risk mitigation and safety actions and provides process metric information to demonstrate the state of compliance across business process execution.
Support of the Executive Director, R&D Quality, IT and Complex Systems, the Director is responsible and accountable to continually improve the quality and compliance of the BCP Plan such that these systems become enablers to the business and partners of choice.
Work collaboratively to support the build and optimization of the R&D Quality Management System as it relates to business continuity and crisis management. Activities will include providing management analysis and advice on issued BCP-related quality reports and performance metrics.
Act as a key advisor on associated BCP use and will lead “after action” analyses across the division.
Through a principles-based quality approach, uphold the information rights of patients and trial internal participants, strives for data integrity in support of all related BCP business and regulatory decision-making, and is anchored in commitment to scientific integrity, the efficient and effective use of systems, and driving quality proactively.
Assist the Head of Quality, R&D in the execution of any activities in the BCP/Crisis Management space as required.
Effectively engage Quality teams and support R&D Quality partner aligned BCP strategies and processes.
Deliver expertise to the R&D Quality organization and its customers and stakeholders.
Support key partners in inspection efforts and developing responses to regulator BCP/Crisis Management questions as required.
Responsible for other activities/functions within R&D Quality IT and Complex Systems as required and directed by the Executive Director, R&D Quality IT and Complex Systems.
Participate in projects outside of current responsibilities as needed to drive the organization forward to success
Contribute to determining solutions outside of current responsibilities as needed and manage day-to-day operational issues outside of current responsibilities as needed
Education Minimum Requirements:
Bachelor’s degree or equivalent experience.
Advanced academic qualification/degree or equivalent relevant professional experience will be considered.
Required Experience and Skills:
10+ years experience within R&D organizations supporting clinical/regulatory/medical affairs/PV functions, quality management, clinical development; equivalent experience or relevant experience in BCP/Crisis Planning.
5 + years’ experience in working with and directly communicating with leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
Proven ability to function autonomously 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.
Uses rigorous logic and methods to solve difficult problems with effective solutions.
Probes all sources for answers; can identify hidden problems and 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.
Credible, with proven leadership skills to develop and grow next generation of Research & Development Quality professionals.
Work seamlessly with other R&D departments as well as commercial organization and manufacturing organizations.
Driver of innovative and creative solutions for achieving R&D goals and objectives in a high quality and cost-effective manner.
Ability to support highly complex multiple activities simultaneously.
Proven track record to be able to think critically, strategically, independently and problem solve.
High level of motivation, drive, and demonstration of Organon leadership values.
Top notch interpersonal skills in difficult situations.
Driver of change and innovation.
Ability to work seamlessly with all levels of personnel.
Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
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.
Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
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Flexible Work Arrangements:Remote Work
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