Senior Auditor, Quality Assurance

This is a fully remote position, open to applicants in Italy.

📋 Description

• Oversee and execute internal and contracted audits for the Company and its Clients.

• Contribute to the development of audit strategies and risk-based audit planning.

• Lead both process and complex audits.

• Provide Quality Assurance consultancy in the area of GxP expertise.

• Conduct audits of Company partners, vendors, service providers, internal systems, study files, investigational sites, and third parties on behalf of Clients.

• Handle pre-audit preparations.

• Review and approve final CAPA plans within the required timelines.

• Carry out Client PV/QMS system gap analyses and assist in SOP development.

• Serve as the primary QA contact for assigned Clients.

• Plan, execute, and report on audits requested by Clients.

• Participate in commercial meetings pertinent to Quality as a Service.

• Support Quality as a Service initiatives, including mock inspections, training, gap analysis, and revision of procedures.

• Assist in Company audits and inspections conducted by Clients, third parties, and regulatory authorities.

• Develop and mentor Auditors and other quality staff.

• Aid in the creation of the strategic internal audit program.

• Engage in knowledge-sharing and continuous learning and development.

• Author or perform quality control on audit strategies, SOPs, guidelines, and other audit-related procedures.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline is required; a Master’s degree is preferred, or equivalent relevant industry experience.

• Significant prior experience in pharmaceutical and/or biotech pharmacovigilance.

• Strong understanding of GVP & GCP related Quality Management and Assurance.

• Previous experience in GVP and GCP auditing in an Audit Lead capacity.

• Excellent analytical, written, and verbal communication skills.

• Capability to manage assigned tasks and deliver expected outcomes in an organized and timely manner.

• Ability to proactively communicate changes to pre-established goals and deadlines.

• Aptitude for strategic thinking and collaborative work using risk-based, proactive problem-solving approaches.

• Strong team player.

• Proficient in English, both written and spoken.

• Knowledge of additional/local languages is advantageous but not mandatory.

• Up-to-date understanding of international regulatory requirements, guidelines, and best practices.

🏝️ Benefits

• Option for remote work.

• Collaborative team atmosphere.

• Opportunities for continuous learning and professional development.

• Access to training opportunities.

• Chance to positively impact patients’ lives.

• Diverse and inclusive work environment.

• Opportunities for career growth.

• Collaborative partnerships within a passionate expert team.