• 20 years of Strategic Advisory, Risk Management, SaaS (Cloud) Governance in Regulated Environments, Quality / Learning Management Systems, Information Solutions / IT Compliance, Computer Software Assurance, Computer Systems Validation, Change Management, Data Integrity, Cybersecurity/ GDPR Evaluation and GxP Audit Management expertise in the Life Science industry (Biotechnology Pharmaceuticals, Medical Devices, GMP, GLP, GCP, PV, CROs, CMOs, FDA / EMA regulations).• Quality Leadership experience, managing small to large teams. • SaaS Governance / Cloud Computing Validation and Compliance expertise. • Quality Management Systems expertise (creation and implementation of Quality Manuals, Policies, Procedures, and Inspection Readiness / Remediation Programs).• Risk Management and Gap Remediation expertise. • Internal and external Audit Management expertise (evaluation / qualification of cloud-based providers)• Change Management and Computerized Systems Lifecycle Management expertise.• Electronic Records, Electronic Signatures (CFR 21 Part 11 and Annex 11) expertise. • Hands on experience on developing Quality, IT / SOX Compliance, Computer Systems Validation, Computer Software Assurance, Cloud Governance, Data Integrity, Learning, Vendor and Change Management programs.• Hands on experience on DRP and BCP programs for businesses and complex regulated systems. • Hands on Computer Systems Validation and IT Compliance implementation experience on all major GxP software systems. • Ability to create pragmatic, risk based defendable approaches, while balancing regulatory requirements with business needs.