Damien Sharp

About Damien Sharp

At the helm of AstraZeneca\'s Software as a Medical Device (SaMD) Quality Management…

Experience

1. Global Quality Director - Medical Device Software Quality Systems

   AstraZeneca

   Oct 2018 — Present

   Responsible for the creation and implementation of a Software as a Medical (SaMD) Quality Management System (QMS) within AZ • Contributes to the definition of the SaMD strategy in within AZ • BPO for the Quality Management System for Software as a Medical Device QMS • Contributes/leads significant local/cross functional or global projects/initiatives and influences decision making within Quality Assurance and the line functions/skills groups, including senior management • Manages or leads functional input to global projects to deliver elements of the quality strategy/regulatory compliance. • Front facing Subject Matter Expert for internal and external audits • Collaboration with internal stakeholder functions (IS, Corporate Quality, Device Engineering, Commercial, Regulatory Affairs, etc.) to ensure a risk-based, robust, and integrated methodology • Benchmarking with industry regarding quality and compliance models for software devices • Provides expert SaMD knowledge that current regulatory trends are researched, evaluated and accommodated in software app development • Manages risk using evaluative judgement in complicated or novel situations • Understanding and application of Agile and waterfall software development methodology • Ensuring inspection readiness for software devices • Training and mentoring relevant staff for development and succession planning in this space • Maintaining and resourcing program and project quality support portfolio for software devices • Interfacing with Senior Management to build support and provide updates • Data management and presentation • Providing backup support to other Device Quality focus areas, and potentially interfacing with Regulators • Participate as Lead Auditor for audits of software development partners Projects to develop and optimize these programs will focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches

Education

• American InterContinental University

  Bachelor of Business Administration - BBA

• American InterContinental University

  Bachelor of Science, Accounting and Finance

• University of Maryland Global Campus

  Master of Science - MS, Biotechnology - Regulatory Affairs

• Notre Dame of Maryland University

  Associate of Arts - AA, Business Administration and Management, General

• University of Maryland

  Master of Science, Biotechnology

Skills

• 21 Cfr Part 11
• Lims
• Software Documentation
• Gmp
• Connect
• Clinical Practices
• Continuous Improvement
• Haccp
• Validation
• Compliance Wire
• Edm
• Sop
• Pharmaceutics
• Quality Management
• Regulatory Affairs
• Sap
• Cross-Functional Team Leadership
• Maximo
• Quality System
• Iso
• Medical Devices
• Pharmaceutical Industry
• Change Control
• Quality Assurance
• Six Sigma
• Fda
• Quality Control
• Root Cause Analysis
• Biotechnology
• Etq
• Citrix
• Trackwise
• V&V
• Capa
• Quality Auditing
• Computer System Validation
• Gxp