Spclst, Compliance & Risk Management-2

Job Description

Position Overview: (Basic Functions & Essential function(s) includes, but is not limited to)

The Specialist of Compliance & Risk Management will be responsible for the quality and compliance aspects of computerized systems and supporting infrastructure to ensure compliance with company policies, procedures, and regulatory expectations.

The Specialist of Compliance & Risk Management is responsible for supporting the organization’s compliance and regulatory requirements like  Good Manufacturing Practice (GMP), Sarbanes-Oxley (SOX) Act by evaluating and documenting IT General Controls (ITGC) and related processes.

This role works closely with Business SMEs, IT, Automation, Internal Audit, and external auditors to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement and to ensure the effectiveness of controls..

The Specialist of Compliance & Risk Management must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Main Activities: (Primary activities include, but are not limited to)

Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems and infrastructure are in place and effective.

The Specialist will manage the change management to ensure compliance.

Ensure that the Computer System Validation (CSV) and SOX ITGC Controls were identified and addressed for the deployment / update, working 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 audits.

Monitor changes in IT systems and processes that may impact – compliance and regulatory requirements.

Provide training and guidance on - compliance and regulatory requirements.

Skills:

Qualification:

Bachelor's degree.  Preferably Information Systems, Computer Science, Engineering, Pharmacy or equivalent.

Preferable Professional certifications such as CSOPTM or equivalent

Fluent English Speaker

Experience :

Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.

Hands-on experience and understanding of systems supporting pharmaceutical companies and IT risk management

Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.

Good understanding of applicable Standards related to computerized systems development, implementation & Operations.

Familiarity with frameworks such as COBIT, NIST,  ISO 27001 or SOX 404.

Good understanding of GMP and ITGCs and their implications, Limited supervision required in day-to-day activities.

Excellent analytical, communication, and documentation skills.

Preferred Competencies and Skills:

Operate as part of a self-directed team in carrying out day to day functions and assigning priorities

Business engagement skills, with ability to collaborate with both technical and non-technical roles.

Multi-lingual capabilities preferred.

Excellent oral and written communication skills including persuading others and developing cross functional relationships.

Analytical problem-solving skills applied to issue identification and resolution.

Listening, integrating diverse perspectives, adds value to the achievement of team goals.

Timely decision making.

Project management skills combined with a since of urgency and a proven history producing quality deliverables.

Ability to respond to changing priorities.

Inclusion 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 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