Senior Auditor, Quality Assurance

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 the formulation of audit strategies and risk-based audit planning.

• Lead complex audits and process evaluations.

• Offer QA consultancy within the realm of GxP expertise.

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

• Manage activities preceding audits.

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

• Execute client PV/QMS system gap analyses and assist in SOP development.

• Act as the principal QA contact for assigned clients.

• Plan, execute, and document client-requested audits.

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

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

• Support company audits and inspections conducted by clients, third parties, and regulatory bodies.

• Develop and mentor 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 writing or quality control of audit strategies, SOPs, guidelines, and other auditing procedures.

⛳️ Requirements

• 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.

• In-depth knowledge of GVP and GCP-related Quality Management and Assurance.

• Previous GVP and GCP auditing experience 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 fashion.

• Proficiency in proactively communicating changes in established goals and deadlines.

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

• Strong team player.

• Fluent in English, both written and spoken; proficiency in additional/local languages is a plus but not mandatory.

🏝️ Benefits

• Option for remote work.

• Collaborative and passionate team atmosphere.

• Opportunities for professional growth and personal development.

• Knowledge-sharing and continuous learning opportunities.

• A diverse and inclusive workplace where every voice is valued.