Leads Validation and Compliance
In this role, you will oversee the validation and compliance of computerized systems within a site. This involves leading cross-functional teams to ensure regulatory requirements are met.
The ideal candidate has experience in CSV & Compliance with strong knowledge of global regulations such as FDA EMA MHRA.
Main responsibilities include:
* Leading planning execution documentation Computer System Validation activities ensuring compliance with global regulatory requirements developing maintaining validation master plans risk assessments protocols IQOQPQ reports collaborating IT QA manufacturing laboratory teams ensuring validated maintained compliant state managing audits inspections related data integrity serving SME during regulatory inspections driving continuous improvement processes leveraging industry best practices emerging technologies CSA cloud-based systems overseeing implementation maintenance data integrity compliance frameworks providing training mentorship team members stakeholders CSV topics maintaining strong understanding evolving regulatory expectations trends
* Main responsibilities include leading cross-functional teams projects various types technologies such as ERP QMS MES cloud-systems software assurance principles AI/ML digital transformation initiatives regulated environments experience prior involvement difficult rigorous quality management key success critical companies competitive market well-established brands