Manager - IT QA & CSV

Key Responsibilities:

Computerized System Validation (CSV):

• Provide validation expertise on GxP-compliant applications in the drug safety space.
• Serve as SME in CSV practices, ensuring best practices are consistently followed.
• Review and approve key CSV deliverables: Requirement Specifications, Validation Plans, Test Plans, Traceability Matrix, Test Summary Reports, Qualification Scripts, and Validation Summary Reports.
• Lead validation and UAT activities for client product implementation projects.
• Guide the testing team in manual and automated testing, OQ, PQ, IQ, and other SDLC artifacts.
• Support internal QA team during client, internal, and regulatory audits.
• Apply risk-based system validation approaches and the V-Model methodology.
• Collaborate with SMEs for requirements analysis, risk assessment, profiling, and mitigation.
• Oversee Change Control, Deviation Handling, Document Management, and CAPA procedures.

Quality Assurance Operations:

• Maintain strong knowledge of GxP, GDP, GTP, QA best practices and regulatory compliance (FDA, EMA, MHRA, PMDA).
• Ensure adherence to 21 CFR Part 11 and EU Annex 11 guidelines.
• Anchor updates to QMS and participate in continual improvement programs.
• Coordinate revision, review, and approval of IT SOPs and GxP documents.
• Train and mentor resources on QA practices and CSV.

Team and Stakeholder Management:

• Manage, mentor, and coach a team of QA professionals, including onboarding, career development, and performance evaluation.
• Engage with clients to build confidence and maintain relationships.
• Conduct capacity planning and resource forecasting.
• Ensure effective management of multiple projects while maintaining the balance between quality and productivity.
• Oversee cross-training of staff and promote teamwork and motivation.