Organon is a global healthcare and pharmaceutical company focused on women’s health across the lifespan. Its portfolio spans more than 70 medicines and devices, including treatments and products for fertility, contraception, maternal and vaginal health, alongside general medicines such as biosimilars for cardiovascular, neurological, dermatological, autoimmune and respiratory conditions. Organon works across more than 140 markets, with an emphasis on access and affordability and on supporting patients and healthcare professionals.
Compliance and Risk Management Specialist
Oversee computerized system validation, GMP, SOX IT general controls and risk management. Support Organon’s healthcare work for women and their families.
Description
- Review processes and records to confirm compliance for computerized systems and infrastructure
- Coordinate change management to maintain compliance
- Identify and address Computer System Validation and SOX ITGC controls for system deployments and updates
- Assess risks and identify IT general controls for access, change management and IT operations
- Help design, implement and document IT controls
- Work with control owners to correct deficiencies and strengthen controls
- Assist internal and external audit teams
- Track IT system and process changes that affect compliance or regulatory obligations
- Train colleagues and provide guidance on compliance requirements
- Coordinate with business subject matter experts, IT, Automation, Internal Audit and external auditors across the computer system lifecycle
- Carry out duties independently with integrity, fairness and objectivity to protect products and patients
Requirements
- Bachelor’s degree, preferably in Information Systems, Computer Science, Engineering, Pharmacy or an equivalent field
- Professional certification such as CSOPTM or equivalent is preferred
- Fluent in English
- Working knowledge of computerized system validation and compliance principles, theories and concepts
- Practical experience with systems used in pharmaceutical companies and IT risk management
- Understanding of pharmaceutical regulations, including FDA, EU and ICH requirements, 21 CFR Parts 11, 210, 211 and 820, and local regulatory expectations
- Understanding of standards for computerized system development, implementation and operation
- Familiarity with COBIT, NIST, ISO 27001 or SOX 404
- Understanding of GMP and IT general controls
- Strong analytical, communication and documentation skills
- Able to engage and collaborate with technical and non-technical colleagues
- Analytical problem-solving ability
- Project management skills and a track record of producing quality deliverables
- Able to adapt to changing priorities
- Able to work with limited day-to-day supervision
Benefits
- Equal opportunity employer committed to an inclusive workplace
- Relocation is not provided
- Regular employee status
- Travel and credentialing requirements, including applicable vaccination prerequisites, are supported as needed