Executive Director, R&D Quality & Regulatory Affairs Partner

Company: Organon & Co.
Location: Williamsburg
Posted on: September 20, 2022

Job Description:

Job DescriptionOrganon is a Womens 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 womens 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.Were 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, youll 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.Its going to be an exciting futurecome be a part of it!THIS ROLE MAY BE REMOTELY BASED on the U.S. EAST COAST -Anywhere on East Coast - Boston, MA to Atlanta, GAExecutive Director, Research & Development (R&D) Quality Partner, Regulatory Affairs/LabelingThe purpose of the Executive Director, R&D Quality Partner, Regulatory Affairs and Global Labeling is to provide strategic and operational leadership for Regulatory Affairs and Global Labeling quality, compliance oversight, and to execute the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement.Organizational Relationships

• Reports to Head, Research & Development Quality
• Member, Research & Development Quality Leadership Team
• Partners with other Organon RA Leadership to assure consistent professional standards
• Works with all relevant local and global Regulatory Affairs and Global Labeling R&D staffs as requested
• Works with external contacts including Regulatory authorities (if necessary) as it applies to inspection activities, professional scientific groups, and consultants
• Works with appropriate Regulatory Affairs and Global Labeling R&D functional areas to ensure appropriate and proportionate approach to quality and compliance issues and challenges
• Works with external vendors as it applies to quality standards and metrics and adherence with and to Organon policies and practicesPrimary ResponsibilitiesThe scope of this position is global and across partnerships. This position serves as a designated point of contact for R&D functions related to all RA quality activities.The position provides overall Regulatory Affairs and Global Labeling R&D quality support in line with the execution of global quality processes and compliance requirements, while ensuring data and scientific integrity practices are followed and consistent with global policies and procedures.The Executive Director defines operational systems and plans for data collection, analysis, and action to monitor performance and achieve continuous improvement.The Executive Director also manages risk mitigation in RA strategies and provides process metric information to demonstrate the state of quality across business process execution.As a member of the R&D Quality Leadership team, the Executive Director is responsible and accountable to make the quality of RA and Global Labeling services such that these systems become enablers to the business and partner of choice.The Executive Director will work collaboratively to support the build and optimization of the R&D QMS. Activities will include providing management analysis and advice on issued RA and Global Labeling quality reports, performance metrics, and acting as a key advisor on methodologies and tools used to achieve continuous improvement.The Executive Director leads the compliance analysis in complex RA and Global Labeling situations and provides recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.The Executive Director is anchored in commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality proactively.In conjunction with RA Leaders, the Executive Director fosters compliance leadership across procedures and processes, employing quality oversight with reference to regulations as required.The Executive Director shall effectively engage Quality teams and support R&D Quality partner-aligned risk management strategies, plans, and processes.The Executive Director participates in projects outside of current responsibilities as needed to drive the organization forward to success.The Executive Director contributes to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as needed.The Executive Director shall support key partners in inspection efforts and developing responses to regulator questions as required.The Executive Director will be responsible for Regulatory Affairs Knowledge Transfer to R&D Quality and will maintain a current knowledge of industry RA quality trends as needed,The Executive Director will assume responsibility for other activities/functions within R&D Quality as required and directed by the R&D Head of Quality.Qualification, Skills & ExperienceRequired Education:
  • Required: Bachelors degree with at least 15 year's R&D experience OR lesser degree with at least 25+ years' relevant work experience
  • Preferred: Advanced academic qualification/degree
  • Equivalent relevant professional experience will be considered.Required Skills:
    • 15+ years R&D experience or relevant experience in RA, ideally with supporting clinical/regulatory/medical affairs, quality management, biomedical science, clinical development; 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
    • 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%
    • 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
    • Is 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.
    • Must be able to support highly complex multiple activities simultaneously
    • Must have proven track record to be able to think critically, strategically, independently and problem solve
    • Must have 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 collaborationsWho 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 Womens 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.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.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 Womens 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.Residents of Colorado: to request this roles pay range: email: coloradopayact@organon.comJersey City and New York City Positions: to request this roles pay range and benefits, email: jcnycpayact@organon.comUS and PR Residents OnlyIf you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency RuleOrganon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyOrganon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R506845

Keywords: Organon & Co., Newport News , Executive Director, R&D Quality & Regulatory Affairs Partner, Executive , Williamsburg, Virginia