Source Job

• 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.

• Serve as system administrator and execution owner for all electronic GxP systems, maintaining validation and compliance throughout their lifecycle.
• Configure, maintain, and troubleshoot system workflows, user roles, and security models in platforms like MasterControl and Veeva.
• Support audits and inspections as a system subject matter expert, ensuring inspection-ready documentation and data integrity.

Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation. The company provides millions of patients, government partners, and emergency responders with security and peace of mind, operating as a focused, execution-driven organization.

• 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.

• 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.

• 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.