- Ludwigshafen, Rhineland-Palatinate, Germany
- Full-time · Senior
- 5+ years
1–4 jobs· newest first
Full-time · Senior
with an attractive salaryFull-time · Senior
On-site · Full-time · Manager

On-site
+10K new in the last hour
Provide quality oversight and subject matter expertise for GxP computerized systems across GMP, GLP, GCP, and PV-regulated areas within the R&D organization.
Provide quality oversight and subject matter expertise for GxP computerized systems across GMP, GLP, GCP, and PV-regulated areas within the R&D organization.
The role supports the Quality Assurance department, ensuring compliance with FDA and other regulatory requirements. It oversees validation programs, including commissioning, qualification, and computer system validation.
Lead a team of validation professionals, maintain validation master plans, review and approve validation protocols and reports, support commissioning, qualification, and validation activities, manage requalification programs, participate in audits and inspections, drive continuous improvement initiatives, serve as validation SME, coordinate with QA, manufacturing, facilities, engineering, and customers, provide technical training and support.