QA Lead Validation GCP

• Interfaces with customers and vendors representing the company as Quality champion.
• Formulates and maintains quality assurance objectives complementary to corporate policies and goals.
• Support mock preapproval inspections (PAIs) and HA inspections as needed. Proactively research local and global initiatives trends and events that impact the maintenance of compliance. Mentor GCP/PV staff as required. Complete any other request from global GCP Audit. Review and approve audit reports as required and also participate in the Lead Auditor program.
• Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate followup measures according to the Novartis requirements on Management Escalations and other relevant procedures. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Followup Responsible Person (FURP) and Quality Responsible Person (QARP).
• Knowledge of ICHGCP guidelines and ability to review and evaluate medical data
• Designs and implements quality assurance training programs to key personnel in conjunction with managers.
• Prepares and maintains control plans and revises/audits processes responds to customers quality concerns.
• Manage client and regulatory authority audits
• Maintains companywide Quality Management System and ISOand ISO 14155 compliance. Oversee and own SOPs for an entire organization
• Author or Review validation documentation (plans protocols test suites reports etc.).
• Contributes to project discoveries project kickoffs review proposals and statements of work to ensure CSV standards are represented.
• Coordinates clientspecific validation activities with practice leads.
• Enforce QA requirements for IT quality systems with potential GxP impact.
• Support GxP decisions/strategies during validation projects.
• Document applicable deviations and documentation anomalies for computer systems undergoing validation.
• Provides leadership throughout the lifecycle of a project guiding the understanding of the validation process that the project team has through design development and implementation to ensure project requirements are met.
• Review requirements traceability matrices test suites and test executions.
• Travel involved. Other duties as assigned.

• GCP Audits QA QMS and Corporate Quality Management: 60%
• Validation: 40%

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