Spclst, Compliance

Overview

The Position

The Specialist of Compliance & Risk Management will be responsible for the compliance aspects of computerized systems and supporting infrastructure to ensure compliance with company policies, procedures, and regulatory expectations. This role supports the organization’s compliance with the Sarbanes-Oxley Act by evaluating and documenting IT General Controls (ITGC) and related processes, working closely with IT, Internal Audit, and external auditors to ensure the effectiveness of controls over financial reporting. The function should be performed independently, with integrity, fairness, and objectivity to protect products and patients.

Responsibilities

• Manage change management to ensure compliance.
• Identify and address SOX ITGC controls for deployments/updates, in partnership with other ESQ&C areas.
• Perform risk assessments and identify key ITGCs related to access management, change management, and IT operations.
• Assist in the design, implementation, and documentation of IT controls.
• Collaborate with control owners to remediate deficiencies and improve control effectiveness.
• Support internal and external audit teams during SOX audits.
• Monitor changes in IT systems and processes that may impact SOX compliance.
• Provide training and guidance on SOX compliance requirements.
• Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.

Required Education, Experience, and Skills

• Bachelor's degree in Information Systems, Computer Science, Accounting or equivalent.
• Professional certifications such as CSOPTM or equivalent are preferred.
• Fluent English.

• Hands-on experience and understanding of systems supporting pharmaceutical companies.
• At least 3 years of experience in IT audit, SOX 404 compliance, or IT risk management.
• Familiarity with frameworks such as COBIT, NIST, or ISO 27001.
• Strong understanding of ITGCs and their role in financial reporting.
• Good understanding of current pharmaceutical regulations (FDA/EU/ICH), with emphasis on 21 CFR Part 11, 210, 211 and 820, and local regulatory expectations.
• Working knowledge of the principles, theories, and concepts of computerized system validation/compliance.
• Experience implementing systems in a pharmaceutical company.
• Ability to work with limited supervision in day-to-day activities.
• Excellent analytical, communication, and documentation skills.

Preferred Education, Experience, and Skills

• Operate as part of a self-directed team in day-to-day functions and priority setting.
• Understanding of applicable standards related to computerized systems development, implementation, and operations.
• Business engagement skills with ability to collaborate with technical and non-technical stakeholders.
• Multi-lingual capabilities preferred.
• Experience supporting regulatory inspections.
• Excellent oral and written communication skills, including persuading others and developing cross-functional relationships.
• Analytical problem-solving skills for issue identification and resolution.
• Ability to listen, integrate diverse perspectives, and contribute to team goals.
• Timely decision making and project management skills with a track record of delivering quality results.
• Ability to adapt to changing priorities.
• Inclusion-oriented behaviors.

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 women’s health, expanding access to leading biosimilars, and delivering a diverse portfolio of health solutions. Our vision is a better and healthier everyday life for every woman.

As an equal opportunity employer, we welcome applications from candidates with diverse backgrounds and are committed to creating an inclusive environment for all applicants.

Important Notices

Search Firm Representatives Please Read Carefully: Organon LLC does not accept unsolicited assistance from search firms for employment opportunities. CVs/resumes submitted by search firms without a valid written search agreement will be the sole property of our company. No fee will be paid if a candidate is hired where no pre-existing agreement exists. Where agency agreements are in place, introductions are position-specific. Please, no phone calls or emails.

Travel, Relocation, and Work Arrangements

• Annualized Salary Range: varies by local market and country.
• Employee Status: Regular.
• Relocation: No relocation.
• VISA Sponsorship: No.
• Travel: No travel required.
• Flexible Work Arrangements: Hybrid.

Number of Openings: 2

Requisition ID: R

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