CURRICULUM VITAE
Accountable for leading compliance for a life sciences account.
Act as Compliance Assurance Lead spanning CSV, Information & Cybersecurity and Service Quality Assurance.
Oversee and manage the compliance aspects for GxP, SOX, GDPR of various IT applications for HR, Finance, Tech Ops, R&D and GxP applications, including coordination with internal/external auditors on quarterly and annual reviews.
Advice clients on acquiring new computer systems and guide them on organizational change management.
Act as the Subject Matter Expert (SME) for software verification and validation requirements, information security, cybersecurity, system resilience and availability, and providing associated guidance and training to applicable staff.
Review KPIs/metrics to maintain the effectiveness and improve the internal quality management systems.
Partner with Quality, Legal, and Accounting to identify associated IT-compliance control gaps (GxP, SOX) and oversee the entire IT-compliance-control portfolio's documentation, implementation, and testing.
Responsibilities include building the team, developing its capabilities, and managing the departmental budget while ensuring profitability.
Maintain an active awareness of current and proposed regulatory standards and industry best practices that may impact QA requirements and information security.
Actively work on continuous compliance improvement initiatives
Responding to external audits