Senior Auditor, Quality Assurance

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

📋 Description

• Oversee and execute internal and third-party audits for the Company and its Clients.

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

• Lead complex audits and process evaluations.

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

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

• Effectively manage pre-audit preparations.

• Review and endorse final Corrective and Preventive Action (CAPA) plans from contracted audits within the designated timelines.

• Conduct Client Pharmacovigilance/Quality Management System (PV/QMS) gap analyses and assist in the development of Standard Operating Procedures (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.

• Assist Quality as a Service initiatives, including mock inspections, training, gap analysis, and the drafting/revision of procedures.

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

• Collaborate with Quality leadership to develop and educate auditors and other quality personnel.

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

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

• Engage in knowledge sharing and continuous professional development.

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

⛳️ 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 pharmacovigilance within the pharmaceutical and/or biotech sectors.

• In-depth understanding of Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) related Quality Management and Assurance.

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

• Strong analytical, written, and verbal communication abilities.

• Capability to manage assigned responsibilities and deliver expected outcomes in an organized and timely manner.

• Proactive in communicating changes to established goals and deadlines.

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

• Excellent team-oriented mindset.

• Proficient in English, both written and spoken; knowledge of additional/local languages is advantageous but not mandatory.

🏝️ Benefits

• Option for remote work.

• A passionate and collaborative team of specialists in clinical research, pharmacovigilance, and quality consulting.

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

• Continuous learning and development opportunities.

• Prospects for professional growth.