AX-7191 Senior GCP Quality Auditor
A key role within the Global Quality Audit team for a specialty driven biotechnology company. Planning and leading
GCP audit activities for systems, vendors, and investigators, working in conjunction with R&D and commercial.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
Launches anticipated over the next 2 years
- This Global Quality Auditor role involves conducting and managing audit activities that serve to monitor compliance of the R&D clinical operations activities with applicable regulatory requirements and company policies and procedures.
- As a member of the Global Quality Audit team, the incumbent must ensure that audits are planned, conducted, followed up and managed in accordance with company procedures as part of a Quality Management System to ensure a high standard of compliance with regulatory guidance
- Maintenance of the Global Quality audit schedule for audits within scope of this GCP role to ensure completion and adherence to the schedule. Audits include but are not limited to GCP audits of systems, vendors, investigator and document audits. In addition, participation at Commercial Operations offices and other audits as required
- Leading, planning, audit conduct and reporting of routine and non-routine audits in accordance with the approved schedule
- On time delivery of audit reports and review of CAPA plans in accordance with internal timelines
- Contributes to the GQA team by conducting peer review of audit reports conducted by other team members
- Manage audit travel and obtaining appropriate travel documentation as required to perform international audits
- In cooperation with R&D, advise and support company in devising and executing remediation actions to ensure compliance to regulatory and Global Quality expectations and requirements.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- A minimum of a bachelor’s degree is required
- Significant experience in conducting global GCP audits with experience in Regulatory inspections management
- Demonstrable in-depth knowledge of GCP requirements and regulations
- Lead Auditor Certification preferred
For a confidential discussion please telephone Stuart Gregory at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button.
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