Senior Auditor, Quality Assurance – Pharmacovigilance Audit, GCP Audit

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

📋 Description

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

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

• Lead both process and complex audits.

• Offer QA consultancy within the realm of GxP expertise.

• Manage activities prior to audits.

• Perform audits of company partners, vendors, service providers, internal systems, study files, investigational sites, and third parties on behalf of clients.

• Review and approve final CAPA plans within established timelines.

• Act as the primary QA contact for designated clients.

• Organize, conduct, and report on audits requested by clients.

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

• Assist with mock inspections, training sessions, gap analyses, and the drafting and revision of procedures.

• Support company audits and inspections carried out by clients, third parties, and regulatory authorities.

• Develop and mentor auditors and other quality personnel.

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

• Keep current with international regulatory requirements, guidelines, and best practices.

• Engage in knowledge-sharing and continuous learning initiatives.

• Author or quality-control audit strategies, SOPs, guidelines, and other auditing procedures.

⛳️ Requirements

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

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

• Strong comprehension 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 meet expected deliverables in an organized and timely fashion.

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

• Capacity to think strategically and collaborate effectively using risk-based, proactive approaches to problem-solving.

• Strong team player.

• Fluent in English, both written and spoken.

• Knowledge of additional/local languages is a plus, though not mandatory.

🏝️ Benefits

• Availability of remote work.

• Collaborative team atmosphere.

• Opportunities for professional growth and continuous learning.

• Training and development opportunities.

• Chance to positively impact patients' lives.

• A diverse and inclusive workplace.

• A passionate team of clinical research, pharmacovigilance, and quality consulting experts.