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.
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.
Lead a 12-week Box-to-Box data migration project for Oak Hill Bio.
Manage system administrator duties for SharePoint, Ignite, and Box.
Ensure full Computer System Validation (CSV) compliance with GAMP and GCP regulations.
Frontier helps companies grow full-time, cross-functional teams abroad. It is a fully remote, 150-person subsidiary of Fresh Prints with most of the team based in India and the Philippines.
Support validation and documentation activities for global EDC systems and clinical study operations.
Execute validation test scripts and document results in line with regulatory guidelines.
Maintain validation metrics and assist in reporting for process transparency and performance tracking.
The company partners with global clinical research organizations to support validation and compliance operations. It functions as a mission-driven organization focused on healthcare innovation, operating within a structured, regulated environment.
Deliver high-quality informatics services including deployment, validation, training, and support for Waters solutions in regulated labs.
Provide validation consulting across the system lifecycle, ensuring compliance with GxP, 21 CFR Part 11, and Annex 11.
Act as a trusted advisor, supporting customer relationships, pre-sales activities, and identifying growth opportunities.
Waters Corporation is a global leader in analytical instruments, separations technologies, and software, serving life, materials, food, and environmental sciences for over 65 years. With 7,600+ employees across 100+ countries, the company fosters a collaborative and inclusive culture passionate about pioneering science.
Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.