OT Validation & Quality Lead

Job Title: OT Validation & Quality Lead
Work Location & Reporting Address: Richardson, TX 75082 (onsite from Day 1)
Contract duration: 12 Months
Must Have Skills:
Quality Manual and the relevant regulatory requirements
OT system
Quality management for IT and OT systems
Nice to Have Skills:
Detailed Job Description:
Primary focus is to ensure that the qualification of the OT system, quality management for IT and OT systems, ensuring that the required validation qualification deliverables are implemented according to the client s Quality Manual and the relevant regulatory requirements according to the client s procedures, author, review andor approve various validation qualification deliverables
Review approve validation qualification deliverables as provided by the supplier of the relevant systems, ensure that such deliverables are compliant to the client s requirements
Lead the project test resources in relation to the validation qualifications related activities of the project Act as the projects quality representative in relation to testing activities, engaging with local site QA andor QA eCPL
Report on the status of the various quality-related activities for key stakeholders
Engagement with the suppliers to advise the suppliers on the suitable completion of supplier provisioned validation qualification deliverables.
Minimum Years of Experience:---8 to 10 years
Certifications Needed:---None
Top 3 responsibilities --
Lead the project test resources in relation to the validation qualifications related activities of the project
Review approve validation qualification deliverables as provided by the supplier of the relevant systems, ensure that such deliverables are compliant to the Novartis requirements
Report on the status of the various quality-related activities for key stakeholders