About the Role
This position leads computer system validation and quality compliance initiatives to ensure adherence to regulatory requirements across information systems used in drug development and commercial operations. The role partners with cross-functional teams to implement and maintain compliant systems within a dynamic, regulated environment.
Responsibilities
- Lead validation efforts for computerized systems used in clinical, manufacturing, and quality operations
- Develop and execute validation protocols including risk assessments, test scripts, and summary reports
- Ensure compliance with FDA, EMA, and other global regulatory standards for electronic records and signatures
- Collaborate with IT and functional teams to define system requirements and validation strategies
- Review and approve system documentation such as requirements, design specs, and change controls
- Support audits and inspections by providing validation evidence and subject matter expertise
- Maintain validation lifecycle documentation in alignment with internal procedures and industry guidelines
- Evaluate vendor systems for compliance readiness prior to implementation
- Drive continuous improvement of validation processes and templates
- Train stakeholders on computer system compliance expectations and best practices
- Monitor regulatory trends and update practices to reflect evolving standards
- Oversee remediation activities for systems with compliance gaps
- Ensure data integrity principles are applied across validated systems
- Manage third-party consultants and contractors supporting validation projects
- Support internal investigations related to system deviations or data anomalies
- Participate in system upgrades, patches, and decommissioning activities
- Maintain validation master plans and system inventories
- Ensure alignment between validation activities and project timelines
- Assist in the qualification of cloud-based applications and SaaS platforms
- Promote a culture of quality and compliance across technical and operational teams
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with flexibility based on role and business needs
Team
Part of the Quality Assurance team within a growing biopharmaceutical organization
Why Join Us
- Opportunity to contribute to a mission-driven organization advancing treatments for neurodegenerative diseases
- Collaborative environment that values innovation, integrity, and patient focus
Physical Requirements
- Standard office environment with occasional need to move between workspaces
- Extended periods of computer use required
May offer visa sponsorship for qualified candidates
