Sr. Specialist, Business Ownership & Compliance Governance

Job Description

Summary

The Sr. Specialist, ESQC Business Ownership & Compliance Governance is responsible for establishing and sustaining a robust Business Owner Community of Practice across enterprise and site-level computerized systems. This role serves as the primary liaison between ESQC, Business Owners, System Owners, and key stakeholders to ensure compliance responsibilities are clearly understood, communicated, and executed effectively.

Key Responsibilities

• Partner with Business Owners, System Owners, ESQC, and IT organizations to ensure computerized systems are appropriately identified, classified, governed, and maintained throughout their lifecycle.
• Maintain a strong network of Business and System Owners through a Community of Practice, for effective knowledge sharing, communication, and alignment of compliance expectations.
• Coach, mentor, and support Business Owners in fulfilling their compliance responsibilities related to computerized systems and associated business technology processes.
• Develop, implement, assign, and monitor training curricula for Business and System Owners to ensure role-based compliance knowledge, and competency.
• Drive timely completion of compliance activities, including Periodic Reviews, User Access Reviews, Problems, Deviations, CAPAs, and corrective actions.
• Support inspection readiness through planning, coordination, and participation in internal audits, external audits, and regulatory inspections.
• Develop, maintain, and continuously improve governance metrics for visibility into compliance performance, risks and improvement opportunities.
• Perform additional responsibilities as assigned by management in support of organizational objectives.

Required Education and Experience

• BS degree in Life Sciences, Information Technology, Engineering, Quality, or related discipline.
• 5+ years of experience in pharmaceutical quality, compliance, computerized systems, or related GxP environments.
• Strong working knowledge of computerized systems, IT processes, and corresponding business operations.
• Working knowledge of GxP regulations, Computerized System Validation (CSV), Data Integrity, and Quality Management Systems.
• Experience supporting compliance processes such as Periodic Reviews, User Access Reviews, Deviations, CAPAs, Change Management, and Audit/Inspection Readiness.
• Experience developing compliance metrics, dashboards, and governance processes.

Preferred Education / Skills

• Strong collaboration, communication, and stakeholder management skills.
• Strong analytical, problem-solving, and continuous improvement skills.
• Experience developing, implementing, and managing training programs and curricula.
• Experience supporting regulatory inspections and internal/external audits.

Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants.

Secondary 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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. 

Annualized Salary Range

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:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1