Senior Auditor, Quality Assurance

Job Description The Senior Auditor, Quality Assurance role is a senior role that effectively manages and conducts internal and contracted audits for the Company and for Company’s Clients. The role provides input into audit strategy and risk-based audit planning and leads process and complex audits, as well as providing QA consultancy activities within their area of GxP expertise. Core responsibilities of the Senior Auditor are: Auditing Within area of their GxP expertise, conduct audits initiated by the Company, or contracted by small to mid-size Clients, according to the agreed Audit Program including effective management of pre-audit activities. Audit types may include: Audits of Company Partners and Vendors/Service Providers Internal System Audits Study audits (e.g. of study files, investigational sites) Audits of Third Parties on behalf of Clients (e.g. including MAH PV System, Vendors, MAH Affiliate/ Partner Audits). Reviews and approves all final CAPA plans from contracted audits within timelines mandated by Company/ Client procedures Consultancies e.g. Client PV / QMS system gap analysis, SOP development, etc. Main QA contact for designated Clients and plans, conducts and reports on audits requested by Clients Quality as a Service Attend commercial meetings related to Quality as a Service Supports Clients with a wide variety of Quality as a Service activities, including Mock inspections Training Gap analysis Procedure drafting and revision Other Supports audits and ins