Specialist, Compliance & Risk Management

Organon

. Review processes and documentary evidence to verify compliance activities for computerized systems and infrastructure .

Posted 10/13/2026full-timeSao Paulo • BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computer System Validation, compliance with FDA/EU/ICH regulations, and IT General Controls (ITGCs) within the pharmaceutical industry. Proficient in risk assessment, change management, and collaboration with cross-functional teams to enhance compliance and control effectiveness.

Highest-signal resume keywords

Computer System ValidationIT General Controls (ITGCs)Pharmaceutical Industry RegulationsRisk AssessmentChange Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Compliance PrinciplesRisk ManagementGMP UnderstandingProject ManagementAnalytical Problem-Solving

Soft Skills

Communication SkillsCollaboration SkillsAnalytical Skills

Tools & Technologies

COBITNISTISO 27001SOX 404

Certifications & Qualifications

CSOPTM

Industry Keywords

FDA RegulationsEU RegulationsICH Guidelines21 CFR Parts 1121 CFR Parts 21021 CFR Parts 21121 CFR Parts 820

About the role

Key responsibilities & impact

Review processes and documentary evidence to verify compliance activities for computerized systems and infrastructure
Manage change management activities to ensure compliance
Ensure Computer System Validation and SOX ITGC controls are identified and addressed for deployments and updates
Perform risk assessments and identify key ITGCs for access management, change management and IT operations
Assist in designing, implementing and documenting IT controls
Collaborate with control owners to remediate deficiencies and improve control effectiveness
Support internal and external audit teams
Monitor IT system and process changes affecting compliance and regulatory requirements
Provide training and guidance on compliance and regulatory requirements
Work with Business SMEs, IT, Automation, Internal Audit and external auditors throughout the computer system lifecycle
Conduct responsibilities independently with integrity, fairness and objectivity to protect products and patients

Requirements

What you’ll need

Bachelor's degree, preferably in Information Systems, Computer Science, Engineering, Pharmacy or equivalent
Preferable professional certifications such as CSOPTM or equivalent
Fluent English speaker
Working knowledge of computerized system validation and compliance principles, theories and concepts
Hands-on experience with systems supporting pharmaceutical companies and IT risk management
Understanding of pharmaceutical industry regulations, including FDA/EU/ICH, 21 CFR Parts 11, 210, 211 and 820, and local regulatory expectations
Understanding of standards related to computerized systems development, implementation and operations
Familiarity with COBIT, NIST, ISO 27001 or SOX 404
Understanding of GMP and ITGCs
Excellent analytical, communication and documentation skills
Business engagement and collaboration skills with technical and non-technical roles
Analytical problem-solving skills
Project management skills and proven history producing quality deliverables
Ability to respond to changing priorities
Ability to work with limited day-to-day supervision

Benefits

Comp & perks

Equal opportunity employer committed to an inclusive environment
No relocation
Regular employee status
Travel and credentialing requirements, including associated vaccination prerequisites, supported as applicable