Senior Auditor, Quality Assurance – Pharmacovigilance Audit/GCP Audit

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

📋 Description

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

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

• Lead complex and process audits.

• Provide QA consultancy services within the scope 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 approve final CAPA plans from contracted audits within set timelines.

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

• Serve as the primary QA contact for assigned Clients.

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

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

• Support Quality as a Service initiatives, including mock inspections, training, gap analysis, and procedure drafting and revisions.

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

• Collaborate with Quality leadership to develop and train Auditors and other quality personnel.

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

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

• Engage in knowledge-sharing and continuous personal and professional development.

• Participate in writing or quality control of audit strategies, SOPs, guidelines, and other documented procedures.

⛳️ Requirements

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

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

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

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

• Excellent analytical, written, and oral communication skills.

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

• Capability to proactively communicate changes in established goals and deadlines.

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

• Strong team player.

• Fluent in English, both written and spoken.

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

🏝️ Benefits

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

• Diverse and inclusive workplace where every voice is valued.

• Opportunities for continuous learning and development.

• Knowledge-sharing and learning opportunities.

• Chance to make a difference by assisting in the delivery of safe and effective pharmaceutical treatments to patients worldwide.