Director, Quality Management System Governance and Risk Management

Jersey City, NJ, United States

Job Description

The Position

The Director, Quality Management System (QMS) Governance, Quality Planning, and Risk Management is accountable to deliver and execute against our QMS strategy and ensure the health of Organon's Quality Management System, including key governance deliverables. This role is essential to f oster understanding of the Quality Management System across the enterprise. This role assures regulatory & corporate compliance through process monitoring (risk & issue management, KPIs, Metrics), decision making, and ensuring escalation pathways.

Responsibilities

Develop an executable Quality Management System (QMS) Roadmap, including a plan for QMS evolution.

Lead our Company's Quality & Compliance Council for agenda-driven decision-making and issue escalation.

Determine the ETQ Development strategy as the standard for Documentation Control, Change Control, Deviations, Audits, and Inspections.

Identify Company-owned Metrics/KPIs/QMS health elements and Quality Tolerance Limits (QTLs).

Develop and manage a plan to oversee and identify areas of opportunity (health checks) within our Company's Quality Management System components, including Quality Assurance, Quality Control, Quality Improvement, Quality Culture, Quality Metrics, and Quality Objectives.

Develop and execute the ORD Quality Plan, including annual Quality Objective Setting, Risk Assessment, and Management across Organon's functional areas.

Collaborate on Organon's QMS and Governance strategy and execution.

Execute our Company's training Compliance Monitoring Program to detect trends, risks, and determine data driven solutions/mitigations.

Contribute to determining solutions and participate in projects/initiatives outside of current responsibilities to drive the organization's success, as needed.

Required Education, Experience and Skills

Bachelor’s degree or equivalent relevant experience.

Ten plus years' experience working within a matrixed Pharmaceutical or Medical Device Quality Organization.

Five plus years interfacing directly with Senior Leadership.

Medical Device regulations experience a plus.

Data driven decision making.

Meeting Facilitation.

Managing change impacts across large and diverse teams.

Collaboration on root-cause.

Self-motivated, leads independently.

Owns it.

Embraces and Demonstrates Organon Values.

Expert – Communication with all impacted stakeholders; Synthesizes information to inform Departmental, Functional Area strategy.

Expert – Demonstrated success driving Risk Management and Quality Objective implementation.

Advanced – Leadership, self-awareness, interpersonal relationships. Collaborative, self-starter able to work seamlessly with various levels of leadership across the enterprise.

Advanced – proven ability to think creatively; develop and execute strategic plans with attention to execution detail.

Advanced – Understands the R&D Business Model, including clinical/regulatory/medical affairs/PV functions, and how it interfaces with key enterprise-wide stakeholders (OEC, OMS, Commercial).

Expert – Thorough data and information collection; ability to gather requirements to inform critical business decisions.

Expert – Ability to drive Quality Management System discussions/decisions to promote a robust ORD adoption of the QMS

Advanced - ETQ 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)

$150,600.00 - $256,300.00 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 Relocation:

No relocation VISA Sponsorship:

No 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:

1

Requisition ID: R527029

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