Senior Specialist, Quality Management System Process and Data Excellence

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Senior Specialist, Quality Management System Process and Data Excellence

Apply locations USA - Pennsylvania - Plymouth Meeting USA - New Jersey - Jersey City time type Full time posted on Posted Yesterday job requisition id R527030

Job Description

The Position

The Senior Specialist Research & Development (R&D) position will be responsible, under the direction of our Company's Compliance and Quality Management System (QMS) Excellence Lead, for executing against strategy to maximize the use of QMS technologies & platforms through data, supporting key governance activities related to our Company'sQuality Management System, and simplifying how we represent process and tools we need to succeed, in addition to supporting other key team deliverables.

Responsibilities

Delivers technology roadmaps, reflecting Organon's Compliance Data Sources (Inputs / Outputs / Repositories), Quality dashboard development and Data Flow across Q&C.

Gathers data and requirements to support the build and optimization of Organon's QMS.

Executes Critical Process Mapping / Process Optimization for our Company.

Leads the execution of the QMS Dashboard development plan.

Manages Organon's Q&C Process Forum execution, project, and action item tracking.

Supports Compliance Council (coordinates data, meeting materials, action item tracking) as well as our Company's Training Compliance.

Provides executional support to other areas of QMS Excellence and Governance for prioritized projects, including change control, quality documentation.

Delivers technology roadmaps, reflecting our Company's Compliance Data Sources (Inputs / Outputs / Repositories), Quality dashboard development and Data Flow across Q&C.

Supports the day-to-day business of QMS Excellence, Governance, as well as other Q&C Operational activities.

Ensures Q&C Team Communications Platforms (MS Teams Channels, Governance Council SharePoint, Team Meetings) are kept current and efficient.

Works in partnership with others within the Company, and external partners to accomplish quality goals; demonstrates leadership.

Required Education, Experience and Skills

Bachelor’s degree or equivalent relevant experience.

Strong verbal and effective writing skills.

Highly organized work efforts and task prioritization.

Understands the R&D Business Model, including clinical / regulatory / medical affairs / PV functions.

Proficient in MS Office Software (Outlook, PowerPoint, Excel, Word) Collaboration tools such as MS Teams, SharePoint, as well as Power BI;

MS Visio, NIMBUS, or other process mapping tools / methodologies.

Thorough data and information collection; ability to gather requirements to inform critical business decisions regarding ORD Process, Quality Management System.

Embraces and Demonstrates Organon Values.

Collaborative, self-starter able to work with various levels of leadership across the enterprise.

ETQ experience preferred (QMS Technology platform).

Secondary Language(s) Job Description

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.

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 [email protected] .

For more information about personal rights under Equal Employment Opportunity, visit :

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

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.

Applicable to United States Positions Only : Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.

Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and / or prior work experience.

The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver / parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$92,400.00 - $157,100.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note : Pay ranges are specific to local market and therefore vary from country to country.

Employee Status : Regular

Regular

Relocation : No relocation

No relocation

VISA Sponsorship :

Travel Requirements : Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

No Travel Required

Flexible Work Arrangements :

Work Week

Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings : About Us

About Us

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas.

We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing.

Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today.

Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.

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