Digital Technology, Computer System Assurance Expert

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the execution of Computer System Assurance (CSA) projects for computerized systems.

• Ensure that projects adhere to global regulations and internal quality standards.

• Convert the enterprise risk-based validation/qualification strategy into implementable project plans.

• Lead teams in developing validation/qualification packages that ensure data integrity and technology implementation.

• Create and execute risk-based validation plans for designated computer system projects.

• Manage the creation and review of validation lifecycle documentation, including Validation Plans, Test Plans, and Traceability Matrices.

• Direct daily validation testing and collaborate with project teams, business users, and Digital Quality.

• Maintain the validated status of systems through change-control validation activities and regular reviews.

• Act as the primary validation contact for assigned projects.

• Offer expert guidance and resolve challenges at the execution level.

• Collaborate with project teams to ensure validation deliverables are completed on time and meet high-quality standards.

• Promote continuous improvement of the risk-based CSA process by providing feedback on project execution.

• Provide direction and support for validation and qualification tasks.

⛳️ Requirements

• Bachelor's or Master's Degree preferred in Life Sciences, Engineering, Computer Science, Information Systems, or related fields.

• 5+ years of experience in a validation role managing the validation of GxP computer systems in a biopharmaceutical or medical device environment.

• 5+ years of experience in authoring and executing validation deliverables, including Validation Plans, IQ/OQ/PQ protocols, and Traceability Matrices for complex systems.

• Experience in leading project teams or managing the work of validation specialists or contractors is a plus.

• Proficient in developing project-level validation plans and executing validation documentation and testing (CT/FT/UAT).

• Familiarity with the system development lifecycle (SDLC) and project management principles.

• Proven communication skills in a multicultural and multilingual global environment.

• Demonstrable experience in project management, proactive planning, priority setting, and securing alignment.

• Ability to collaborate effectively within cross-functional teams and networks.

• Adaptability, comfort with ambiguity, trust-building, and resilience.

• Willingness and ability to engage in continuous learning, self-improvement, and development.

🏝️ Benefits

• Short-term and long-term incentive programs, subject to the terms and conditions of the applicable plans and policies.

• Comprehensive benefits package.

• Retirement savings plans.

• Health benefits.

• Equal consideration for employment without discrimination.

• Reasonable accommodation during the application, interviewing, and candidate selection process.