Risk & Compliance Specialist

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Job Description

About the role:
The SCO – Validation Lead is responsible for managing the global information security risk program across the organization. This individual will work directly with business leaders to understand security and risk issues, oversee risk management and assessment efforts, and develop effective remediation programs.

Key Responsibilities

• Develop and execute a strategic CSV plan that aligns with the company's overall compliance and quality objectives. This includes defining validation strategies, risk assessment methodologies, and validation lifecycle models.
• Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.
• Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.
• Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.
• Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.
• Work with other departments to ensure alignment for an agreed upon state of control for computer systems.
• Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.
• Manage a team of professionals to drive validation activities for computer systems.
• Work with other departments to ensure alignment for an agreed upon state of control for computer systems.

Qualifications

• +5 years of experience in a similar role
• Bachelors or Master's degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields).
• Extensive experience in computer system validation, particularly in laboratory, R&D and clinical trial environments.
• In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Attention to detail and a commitment to data integrity and quality.

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