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.
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.
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.