Associate Director DPOC Process and Systems

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!

Responsibilities:

• Lead and coordinate IT/IS projects, data and systems in support of the company’s Global Medical Affairs Capability (GMAC).

• Identify opportunities for additional process improvements, innovations and systems enhancements/upgrades with focus on System Support and Systems and Process Execution.

• Partner within GMAC and across business functions and geographies to make effective decisions, solving complex problems with efficient solutions and escalating risks and issues.

• Collaborate with key stakeholders to design, develop and utilize metrics for quality and efficiency assessment and continuous improvement recommendations.

• Respond and comply with program investigations, audits, or assessments.

• Serve as the Process & System Coordinator for multiple processes and systems leveraged by GMAC and implement processes utilizing improvement methodologies.

• Monitor and evaluate process changes to ensure benefits/objectives are being met and are measurable.

• Facilitate program training and maintenance of program-related reference guides and/or training documents on both the process and the applicable system.

• Adhere to the compliance and regulatory procedures, working closely with Global Compliance and Legal.

• Engage cross-functionally across the organization to develop test and implementation plans, drive results and resolve issues.

• Must have Master’s degree in Computer Science, Computer Information Systems or Chemical Engineering.

• Must have 2 years experience in the area of computer systems validation, providing IT risk management and compliance services support for IT/computer systems projects within Life Sciences and Healthcare industry, including providing recommendations for process improvements, risk evaluation and mitigation.

• Must have experience in leading validation projects for computer systems, analyzing technical requirements, developing testing documentation, and designing, assessing and transforming processes to mitigate risk and achieve compliance.

• Experience utilizing SAP for Material Management, Manufacturing, Sales and Distribution, Production Planning, Logistics, Quality Management and Human Resources and knowledge of cGxP regulations and ISPE GAMP5 Computer Validation Life Cycle also required.

Telecommuting permitted. To be considered, create a profile and submit your CV for Job R516378

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.com

Jersey City, New York City, Washington State & California 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:

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Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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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.

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Requisition ID:R516378