• Lead a global cross-functional squad accountable for the design and maintenance of the following Global Quality Processes: Quality Risk Management, Data Integrity, Knowledge Management, Content Management, and Learning• Business process lead for design and change implementation of Quality Risk Management module within eQMS• Drive and contribute to continuous improvement of global processes with input from stakeholder feedback, user input, audit and inspection observations, and performance via metrics• Support audit and inspection findings associated with global enabling processes

• Provide project management for PQS Authors with PQS content changes including alignment with Health Authority requirements to ensure quality and compliance• Managed the PQS Business Process to create alignment with network initiatives such as new eQMS• Represented Global PQS in the design and implementation of cross-functional process improvement initiatives such as PT Data Governance• Acted as an Evolution Coach for the Product Quality team to help colleagues embrace, learn and apply prioritized mindsets and behaviours necessary for the new Operating Model to succeed• Managed the onboarding for multiple new colleagues including creating onboarding plans, coaching, hands-on training, and conducting check-ins

• Contributed to reorganizing team structure and ways of working to lead to a more efficient PQS Business Process and increased job satisfaction amongst the team• Supported Authors and Document Managers in the creation and revision of PQS documentation• Managed PQS dashboards and reports to proactively find areas to continuously improve

• Successfully led and managed projects including product launches, site transfers, and acquisitions/divestments • Worked closely with global and external partners to manage and optimize the supplier qualification and audit program for AstraZeneca Canada for service providers and suppliers • Managed the Drug Establishment License and Medical Device Establishment License to ensure all products are imported as per GMPs and local regulations• Conducted day to day quality activities including batch disposition, SOP authoring, and initiation and review of deviations, change controls and risk assessments• Supported a Health Canada inspection at a foreign AstraZeneca packaging/testing site which resulted in a compliant rating to optimize product testing for Canadian market• Supported local Health Canada GMP inspection resulting in a compliant rating• Presented a Ted Talk on Quality topics to Canadian employees at the 2017 National Meeting

• Managed projects including new product launches, reformulations, local manufacturing/packaging changes, artwork changes, and line extensions• Compilation and review of master production documents in order to launch products to Canadian market• Worked closely with supply chain to lead a project to optimize local third-party packagers resulting in reduced lead times and financial savings

• Provided coaching and leadership to direct reports, supported development plans and conducted performance reviews• Generated forecasts and developed annual budgets for the Quality Department to ensure optimal use of resources• Led face-to-face business consultation meetings with current and prospective clients• Prepared for and led multiple Health Canada on-site inspections (GMP and GVP)

• Worked with senior management to conduct day-to-day clinical and quality activities• Performed periodic self-inspections and third-party audits• Conducted clinical trial monitoring of Phase I and II allergy studies

• Assisted senior management in day-to-day regulatory and quality activities• Prepared regulatory submissions including: ANDSs, SANDSs, NCs, CTAs, and Clarifax responses• Reviewed executed batch release documentation for product releases