Hobson Prior are currently looking for a GxP Senior Quality Auditor for a leading biopharmaceutical company, to be based in the UK on a permanent basis. In this role you will be responsible for managing and performing the global Pharmacovigilance audit activities that help to periodically monitor compliance of activities surrounding Good Pharmacovigilance Practices.
- Accountable for the development and ongoing maintenance of the PV high level audit strategy (3-5-year audit plan)
- Development of the annual audit schedule based on risk assessments and the audit strategy (3-5-year plan)
- Implementation and maintenance of a robust risk assessment process for prioritisation of audits of PV vendors, alliance partners, affiliates and PV systems.
- The execution and documenting of risk assessments as a basis for the strategic, tactical and operational planning of pharmacovigilance audit activity by gathering appropriate information from key stakeholders when required.
- Independently leading, planning, audit conduct and reporting of routine and non-routine audits in accordance with the approved schedule.
- Efficient delivery of audit reports and review of CAPA plans in accordance with internal timelines.
- Oversee audits conducted by PV contractors, including identification of suitable PV consultants, setting up contracts and providing training in accordance with Ipsen procedures.
- Involvement with the GQA team by conducting peer review of audit reports conducted by other team members.
- In collaboration with the audited functions, provides advice and support where required in execution of remediation actions (CAPAs) to ensure compliance to regulatory and Global.
- Contributing to the continuous improvement and maintenance of the GQA and Global QMS by writing SOPs and guidance documents; updating PV report templates, checklists and other documents as required and requested by the GQA director.
- Master's degree in a scientific or health-related field would be preferred.
- Minimum of 7-10 Years of Quality Assurance/Quality Systems experience in a GVP environment and or clinical development, plus a minimum of 5 years of Quality experience in the biotechnology or pharmaceutical industries.
- Minimum of 5 years' experience in regulatory inspections management (MHRA, FDA, EMA).
- A strong understanding of GxP guidance and regulations.
- 2 years of International travel.
- Fluent in English both verbally and written.
- Demonstrable experience of at least 3 years of PV auditing.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.