Serve as a senior expert in computer system validation and computer software assurance, leading validation initiatives and developing reusable frameworks.
Establish and maintain validation strategies, methodologies, and documentation aligned with regulatory standards like cGxP, GAMP 5, and 21 CFR Part 11.
Mentor junior consultants and collaborate with QA, IT, and business stakeholders to ensure effective validation execution across client engagements.
The company is a consulting firm that provides validation and compliance services for life science manufacturers. They have a people-focused culture with opportunities for professional development and growth.
Establish and maintain the firm's validation strategy and standards, ensuring all deliverables align with cGxP, GAMP 5, and data integrity principles.
Maintain and continuously improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, and ETQ, including URS/FRS templates, risk assessments, and IQ/OQ/PQ scripts.
Lead end-to-end client validation engagements, including validation planning, protocol authoring, execution support, evidence review, and validation summary reporting.
A leading consulting firm specializing in ERP, quality management, and manufacturing solutions for life science manufacturers. They implement various ERP and QMS technologies and have a people-first culture backed by Pine Services Group.
Ensure GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards.
Provide quality oversight for computerized system lifecycle activities, including vendor evaluations and system qualification.
Lead investigations for CSV-related deviations and data integrity issues, driving root cause analysis and risk mitigation.
Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-based treatments for psychiatric and neurological disorders. The company is publicly traded on Nasdaq and focuses on scientific rigor to create accessible mental health treatments.