Senior Auditor, Quality Assurance (Pharmacovigilance Audit/GCP Audit experience

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 inspections of the Company performed by Clients/third parties and regulatory authorities Works with the Quality leadership to develop and train Auditors and other quality employees Assists in the development of strategic internal audit program Maintain an up-to-date knowledge of international regulatory requirements, guidelines and best practices and actively participate in knowledge-sharing and learning process to ensure personal and team continuous learning and development Participate in preparation (authoring o