AX-7185 GxP Audit Manager – PV
Play a key role in driving compliance culture through this unique opportunity to further develop your PV Audit experience within a global QA division and at the HQ of a global specialty pharmaceutical organisation. This is an opportunity to provide real QA leadership and oversight across a broad range of safety systems and processes.
Global Pharmaceutical Company
Global Headquarters / Global Remit
National and international travel involved to audit partner organisations
Reporting to Senior Manager PV QA
The main focus of the GxP Audit Manager - PV is to provide quality oversight for pharmacovigilance and device vigilance audit activities, including setting up and maintaining a risk based audit strategy.
Additional responsibilities and tasks:
- Oversee and provide feedback to PV auditors to discuss findings, emerging risks and identify actions to address identified risks, ensuring formal feedback is provided to senior management on a regular basis
- Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements.
- Participate in and support PV client audits, PV Regulatory inspections and device vigilance aspects of notified body audits on behalf of all the company’s legal entities.
- Plan and conduct PV audits of affiliates, vendors, partners and systems in line with the PV audit strategy
- Serves as a PV QA expert within the business, proving advice and guidance to the organisation and its partners.
QUALIFICATIONS / EXPERIENCE REQUIRED:
A life science degree is an essential pre-requisite.
Current experience of quality assurance, a couple of years in which should be focused on pharmacovigilance compliance and auditing.
Proven experience in over-sight of Pharmacovigilance QA activities for commercial marketed products
Experience supporting partner audits and competent authority PV inspections
Strong analytical skills with highly developed quality system knowledge
Excellent influencing skills and ability to establish effective working relationships with personnel at all levels internally and within third parties
Proven experience in auditing a wide range of GVP processes and suppliers
Medical Device Vigilance experience is desirable
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button.
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