Senior Auditor, Quality Assurance (PV/GCP)

About the role

Ergomed Group, which includes Ergomed CRO, PrimeVigilance, Prudentia and ADAMAS Consulting, works with biopharmaceutical companies on clinical trials, safety studies and quality audits. It is looking for a Senior Auditor, Quality Assurance in Madrid, a senior role that manages and runs internal and contracted audits for the company and its clients, contributes to audit strategy and risk-based planning, leads complex audits and provides QA consultancy within its GxP expertise.

Key responsibilities

• Conduct audits within the GxP area of expertise, initiated by the company or contracted by small to mid-size clients, following the agreed audit program, including pre-audit management
• Audit types include partners and vendors, internal system audits, study audits and third-party audits on behalf of clients (e.g. MAH PV system, vendors, affiliates)
• Review and approve final CAPA plans from contracted audits within client-mandated timelines
• Provide consultancy such as PV/QMS gap analyses, SOP development and other QA support
• Act as main QA contact for designated clients, plan, run and report on client-requested audits
• Attend commercial meetings related to Quality as a Service and support mock inspections, gap analysis, procedure drafting and revision
• Support audits and inspections carried out by clients, third parties and regulators, and help train auditors and quality staff
• Help develop the internal audit strategy, author or QC audit strategies, SOPs and guidelines, and keep up to date with international regulations and best practice

Required profile

• Bachelor's degree in a scientific discipline; master's degree preferred or equivalent industry experience
• Strong previous pharmaceutical and/or biotech pharmacovigilance experience, including GVP and GCP quality management and assurance
• Previous GVP and GCP auditing experience in an Audit Lead role
• Fluent English (written and spoken); additional or local languages are a plus

Required skills

• Understanding of GVP and GCP
• Analytical, written and oral communication skills
• Organised, timely delivery and proactive communication of changes in goals and deadlines
• Strategic thinking and collaborative, risk-based problem solving