Analyst - CSV

Role Summary

Analyst - CSV responsible for leading validation activities for applications within an FDA-regulated environment, ensuring compliance with government regulations and corporate policies. The role shapes validation strategy, provides guidance on quality and privacy, and leads testing and validation efforts to accelerate solution delivery while maintaining compliance.

Responsibilities

• Lead validation activities for the applications.
• Provide oversight and guidance on all aspects of the validation of the solution ensuring compliance with all government regulations and corporate policies and procedures.
• Ensure compliance with internal and external privacy policies and requirements.
• Leverage your knowledge and experience to shape the validation approach and strategy of the solution.
• Provide guidance and oversight of computer systems quality and compliance activities, including the review and approval of computer systems validation deliverables as appropriate.
• Build working understanding of configuration and integrations of the solution being implemented to ensure validation activities cover all requirements.
• Influence design and testing decisions to ensure security and privacy risks are considered and mitigated.
• Design effective, streamlined validation processes to accelerate solution delivery leveraging automated configuration verification and testing where possible.
• Lead testing effort on system releases and changes ensuring system remains in a validation state.

Qualifications

• Required: Bachelor’s degree in IT, Engineering, Computer Science or similar STEM qualification.
• Required: Minimum of 5+ years of experience in FDA-regulated industry in a Quality Assurance, Compliance or Computer Systems Validations role, leading and managing qualification efforts for GMP relevant applications.
• Preferred: Experience and knowledge with FDA regulations as they pertain to information and digital solutions, especially 21 CFR Part 11, as well as relevant aspects of corporate privacy requirements.
• Preferred: Experience with risk-based approach to system validation and testing.
• Preferred: Experience in the development and execution of computer validation documentation and standard operating procedures.
• Preferred: Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Preferred: Ability to work independently, and on multiple concurrent project initiatives.
• Preferred: Enthusiasm to learn and share ideas and solutions effectively with management and colleagues.

Skills

• Knowledge of FDA regulations and privacy requirements as they relate to information and digital solutions.
• Risk-based validation and testing approaches.
• Development and execution of computer validation documentation and standard operating procedures.
• Independent work style with ability to manage multiple projects.
• Strong communication and collaboration skills to work with management and teams.

Education

• Bachelor’s degree in IT, Engineering, Computer Science or similar STEM qualification.