# About Ergomed Group
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
# Role
The Senior Auditor, Quality Assurance is a senior role that effectively manages and conducts internal and contracted audits for the Company and for the 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.
Auditing
•Within their area of 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, 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.
•Maintains up-to-date knowledge of international regulatory requirements, guidelines and best practices, and actively participates in knowledge-sharing and learning to ensure personal and team continuous learning and development.
•Participates in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of the Company and/or Client as per operational needs.
# Requirements
•Bachelor's degree in a scientific discipline required; Master's degree preferred, or equivalent relevant industry experience.
•Strong previous pharmaceutical and/or biotech pharmacovigilance experience, including strong understanding of GVP & GCP related Quality Management and Assurance, with previous experience of GVP and GCP auditing experience in an Audit Lead role.
•Analytical, written and oral communication skills.
•Ability to manage all tasks assigned and effectively deliver all expected deliverables in an organized and timely manner.
•Proactively communicate changes in pre-established goals and deadlines.
•Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving.
•Strong team player.
•Fluent in English (written and spoken); additional/local languages a plus, but not required.
