Senior Auditor, Quality Assurance – Pharmacovigilance Audit/GCP Audit

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

📋 Description

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

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

• Lead both process and complex audits.

• Offer quality assurance consultancy within the relevant GxP areas.

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

• Manage activities prior to audits.

• Review and authorize final CAPA plans within specified timelines.

• Execute Client PV/QMS system gap analyses and develop SOPs.

• Act as the primary QA contact for assigned Clients; plan, conduct, and report on audits requested by Clients.

• Participate in commercial meetings associated with Quality as a Service.

• Assist in Quality as a Service initiatives, including mock inspections, training, gap analysis, and drafting/revising procedures.

• Support audits and inspections carried out by Clients, third parties, and regulatory bodies.

• Cultivate and mentor Auditors and other quality personnel through Quality leadership.

• Aid in formulating the strategic internal audit program.

• Stay updated on international regulatory requirements, guidelines, and best practices.

• Engage in the preparation and quality-checking of audit strategies, SOPs, guidelines, and other auditing procedures.

⛳️ Requirements

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

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

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

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

• Exceptional analytical, written, and verbal communication skills.

• Capability to manage assigned responsibilities and deliver expected results in an organized and timely fashion.

• Ability to proactively communicate any changes in established goals and deadlines.

• Proficient in strategic thinking and collaborative work utilizing risk-based, proactive problem-solving approaches.

• Strong team player.

• Fluent in English, both written and spoken.

• Proficiency in additional/local languages is advantageous but not mandatory.

🏝️ Benefits

• Join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

• Work in a diverse and inclusive environment where every voice is valued.

• Access to continuous learning and development opportunities.

• Engage in a knowledge-sharing and learning culture.

• Benefit from training and development opportunities for Auditors and other quality personnel.