Sr. Specialist- Quality Assurance (100% REMOTE)

Job DescriptionOrganon 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!Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create a collaborative global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. This position sponsors the External Network organization ExN. This position will steer projects associated with identified systems and processes within ExN with a focus on SAP (data stewardship) and other computerized systems.This position can be based at any of our company's locations in the world.Primary Responsibilities:Promoting the development, implementation, maintenance, and enhancement of critical processes, systems and master data such as SAP, Appian, Virtual Supply Chain (Ariba) and Global Change Management (GCM) Track wise.

Promoting the development and implementation of strategic projects within the ExN organization.

Ability to learn new systems as they are introduced to the organization.

Compiling, evaluating, and reporting associated metrics.

Functioning objectively and/or within a team setting showing influence to facilitate enhancement of existing business processes and systems and identify and advance performance improvement activities.

Promoting the development and implementation of strategic projects assuring compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations Good Manufacturing Practice (GMP), etc., both domestic and foreign.

Maintains and provides expertise on ExN systems, tools, data, and processes on an ongoing basis, specifically SAP Quality Master Data via the use of specific T-Codes in COMET SAP- including the troubleshooting of SAP issues and the building of new materials in SAP to promote the ExN supply chain.

Provide ongoing systems Subject Matter Expert (SME) support ensuring ExN data and processes run smoothly with no interruption to supply for SAP and Virtual Supply Chain (Ariba)

Establish new or improved processes, tools, and systems and drive consistent, standard business processes across External Quality Organization (EQA).

Serve as the SME for IT project development and implementation within ExN.

accountable, as needed, for serving on teams when IT and Business systems representation is needed related to any systems, data, or processes in relevant areas.

Assist in workload management for Quality Master Data team.

Assist in the preparation, coordination, and delivery of Senior Management presentations.

Operate in a safe and efficient manner and in compliance with the Quality Operations (QO) Safety and Health Policy.

Education Minimum Requirements:Undergraduate degree in Engineering, Science, or related areas of study.

Required Experience and Skills:Minimum 2 years of SAP master data stewardship, business workflow/ material builds via T-Codes and/or reporting knowledge.

Minimum 5 years of experience in manufacturing, including Supply Change, Operations, Quality Assurance and/or GMP environments.

Excellent analytical and computer skills, including software packages used in the maintenance and analysis of data.

Excellent stakeholder management and communications skills.

Ability to work independently with all levels of the organization.

Ability to manage complex projects that span across multiple parts of the ExN (i.e. IT, operations and technology).

Ability to analyze complex business processes, develop and implement solutions, and communicate impact to stakeholders.

Strong management, partnership, and influencing skills.

Ability to work objectively and collaboratively to solve for complex problems, coach and mentor team members and customers, develop and deliver training materials, and ensure compliance to processes.

Preferred Experience and Skills:SAP master data and troubleshooting.

Product change control.

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 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:Travel Requirements:10%Flexible Work Arrangements:Remote WorkShift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R510054