Quality Audit Manager

PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

Role and Responsibilities

• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.
• Monitors compliance within the organisation to ensure early identification and resolution of quality issues.
• Assists in the development and maintenance of the internal Quality Risk Assessment methodology.
• Assists in the development and maintenance of a comprehensive Audit Universe.
• Leads Quality activities in relation to procurement and vendor oversight.
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.
• Conducts other ad-hoc activities as requested by Director of Audit Management and/or Head of Quality.
• Conducts internal system and/or vendor audits initiated by Primevigilance, according to the approved tactical audit plan, including effective management of pre-audit activities.
• Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities.
• Hosts/supports audits (routine, due diligence, qualification) and inspections of Primevigilance performed by clients/third parties and regulatory authorities as agreed with Director of Audit Management and/or Head of Quality.
• Undertakes activities in relation to audits as a service, in relation to conducting audits under supervision, to work with clients on a project level, project management with clients and provide QA PV expertise and knowledge
• Supports the oversight and maintenance of audits as a service audit log via the line management/oversight of the Quality Audits Associate and conduct audit documentation peer review and quality control activities.
• Documents audit findings and recommendations and identify process improvement initiatives via trending data as provided by Quality Management and document them appropriately

• Preferably, degree level education in relevant scientific and/or legal disciplines or equivalent workplace experience.
• Accredited Auditor by RQA or ISO qualification, with significant experience in auditing pharmacovigilance systems to EU and US regulations.
• Requires significant experience in Quality Assurance/Quality Management Roles within a specialist pharmacovigilance service provider.
• Requires significant experience of managing QRM programmes in a heavily regulated environment.
• Requires minimally 3 years’ experience as a lead auditor within a specialist Pharmacovigilance service provider.
• Requires thorough understanding and knowledge of the principles of Quality Management.
• Requires knowledge and understanding of national and international regulations related to Pharmacovigilance and Medical Information.

All your information will be kept confidential according to EEO guidelines.

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.