Senior Auditor - QA Compliance
Ergomed seeks a Senior Auditor in Quality Assurance to lead internal and external audits for the company and its clients in the pharmaceutical and biotech sector. The role involves conducting GxP audits, developing audit strategy, providing quality consulting services, and supporting regulatory compliance across multiple audit types and client engagements.
Responsibilities
Conduct internal and contracted audits for company and clients per agreed audit programs
Lead audits of vendors, internal systems, investigational sites, and third-party partners
Review and approve CAPA plans from contracted audits within mandated timelines
Provide quality consulting services including gap analysis and SOP development
Serve as primary QA contact for designated clients and support quality-as-a-service activities
Requirements
Bachelor's degree in a scientific discipline; Master's degree preferred
Extensive pharmaceutical or biotech pharmacovigilance experience
Proven GVP and GCP audit lead experience
Strong written and oral communication skills
Analytical ability and strategic problem-solving approach
Fluent in English; additional languages beneficial
Ability to manage multiple deliverables and meet deadlines
Responsibilities
Conduct internal and contracted audits for company and clients per agreed audit programs
Lead audits of vendors, internal systems, investigational sites, and third-party partners
Review and approve CAPA plans from contracted audits within mandated timelines
Provide quality consulting services including gap analysis and SOP development
Serve as primary QA contact for designated clients and support quality-as-a-service activities
Requirements
Bachelor's degree in a scientific discipline; Master's degree preferred
Extensive pharmaceutical or biotech pharmacovigilance experience
Proven GVP and GCP audit lead experience
Strong written and oral communication skills
Analytical ability and strategic problem-solving approach
Fluent in English; additional languages beneficial
Ability to manage multiple deliverables and meet deadlines