Company Description Medicine moves forward here. Company Description
Clinical trials, safety studies, and audits make safe and innovative pharmaceutical‑led care possible. Across the Group, our 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.
And this is where we excel. Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. 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
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
Training
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
Participate 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

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.
Fluent in English (written and spoken); additional/ local languages a plus, but not required
You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
Quality: we hold ourselves to the standard patients deserve.

📌 SENIOR AUDITOR - AUDIT QUALITY ASSURANCE (Madrid)
🏢 Ergomed
📍 Madrid