Director Regulatory Operations - Process Operational Excellence

Company: Organon & Co.
Location: Jersey City
Posted on: June 22, 2022

Job Description:

**Job Description**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!Organon is looking for a **Director Regulatory Operations, Process Operational Excellence** . The role will report to the Executive Director of Regulatory Operations for Europe, Middle East, and Africa (EMEA) within Regulatory Operations within Regulatory Affairs and affiliate Pharmacovigilance in the Research and Development organization of Organon & Co.**About the role**This role will provide support across global Regulatory Operations activities, specifically in the continuous improvement of processes, assessment and update of process documentation, and the development of process training and support resources. The role will be accountable for the delivery of a portfolio of process improvement projects and the appropriate prioritization, sequencing, and resourcing of those projects.It will be important for this role to be a conduit of information between the Regulatory Affairs and Affiliate Pharmacovigilance (RAaPV) leadership and the functional areas, regions, and individual process owners across the organization. There is also an expectation to coordinate with key stakeholders in the Quality and Compliance organization, Organon Research and Development (ORD) Business Process Owner Network, Learning and Development, and colleagues in other ORD departments playing similar process roles.A key focus will be providing leadership, support and subject matter expertise (SME) to process owners throughout RAaPV.**Primary Responsibilities**+ Serves as Project Lead for Process Operational Excellence+ Responsible to define the portfolio of process improvement projects+ Prioritize and sequence the work to deliver maximum impact to the business while balancing resource constraints+ Provide teams with strategic direction and guidance in best practices in process improvement and Lean/Six Sigma principles+ Engage with external network to bring in industry best practices and with ORD Learning and Development to incorporate new training concepts+ Liaise with Director of Processes and Quality Business Partner in Quality and Compliance organization+ Support development of ORD Business Process Owner Network and coordinate RAaPV participation+ Independently identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory activities+ Proactively and creatively problem-solves, makes effective and timely decisions while skillfully negotiating to resolve conflicts across functions and between stakeholders+ Ensures project data, including information used to maintain compliance and aid with strategic planning, is accurately reported in databases+ Assume the lead role in the development of processes and documentation. Delegate these project activities to subject matter experts within the department as needed.+ Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders+ Assist with departmental metrics by tracking status of projects, day-to-day production activities, and anomalies.+ Continuously develops and improves leadership and project management skillsets, understanding of drug/vaccine/biologics/device development, and regulatory practices**Role requirements:**+ Required: Bachelor's degree plus 8 years of operations experience (pharmaceutical regulatory affairs a plus)+ Preferred: Bachelor's degree plus 10-12 years of pharmaceutical regulatory operations experience (MBA or advanced degree in process engineering is considered a plus)+ Detail-orientation with the ability to understand the "big picture" and overall strategy of projects/programs+ Experience with project management and leading teams+ Program management and influencing without authority+ Authoring effective process documentation and driving continuous process improvement+ 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+ Excellent written and verbal communication skills including ability to write clearly and concisely to executive audiences+ 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 global collaborations+ Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skills**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.**Residents of Colorado:** to request this role's pay range: email: coloradopayact@organon.comJersey City and New York City Positions: to request this role's pay range and benefits, email: jcnycpay@organon.com .**US and PR Residents Only**If 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 Carefully**Organon 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:**Regular**Relocation:**No relocation**VISA Sponsorship:****Travel Requirements:**10%**Flexible Work Arrangements:**Remote Work**Shift:****Valid Driving License:****Hazardous Material(s):****Number of Openings:**1**Requisition ID:** R509955

Keywords: Organon & Co., Jersey City , Director Regulatory Operations - Process Operational Excellence, Executive , Jersey City, New Jersey