Senior Auditor, Quality Assurance

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 formulation of audit strategies and risk-based planning.

• Lead both process and complex audit initiatives.

• Provide quality assurance consultancy within the realm of GxP expertise.

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

• Effectively manage pre-audit activities.

• Review and endorse final CAPA plans from contracted audits within stipulated timelines.

• Perform Client PV/QMS system gap analyses and assist in the development of SOPs.

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

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

• Assist Clients with mock inspections, training, gap analyses, and drafting/revising procedures.

• Support audits and inspections conducted by Clients, third parties, and regulatory authorities.

• Develop and mentor Auditors and other quality personnel with Quality leadership.

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

• Keep abreast of international regulatory requirements, guidelines, and best practices.

• Engage in the preparation, authorship, or quality control of audit strategies, SOPs, guidelines, and other auditing procedures.

⛳️ Requirements

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

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

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

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

• Proficient analytical, written, and oral communication skills.

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

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

• Strategic thinking and collaborative problem-solving using risk-based, proactive approaches.

• Excellent team player.

• Proficient in English, both written and spoken.

• Additional/local languages are advantageous but not mandatory.

🏝️ Benefits

• Option for remote work.

• Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

• Opportunities for continuous learning and development.

• Training and knowledge-sharing opportunities.

• A diverse and inclusive workplace.

• Chance to make a positive impact on patients’ lives.