AX-7192 PV Audit Manager / GVP Auditor
Ref: AX - 7192
Drive audit strategy as a key member of the Global Quality Audits team for this specialty driven biotech company. Manage and execute global Pharmacovigilance audit activities and contribute to an annual audit program based on documented risk assessments.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
Launches anticipated over the next 2 years
Reporting to Director, Global Quality Audits
- Collaborate with Global Patient Safety key stakeholders, PVQA and the EUQPPV (or deputy) to provide a robust annual audit program based on documented risk assessments.
- Responsible for the development and ongoing maintenance of the PV high level audit strategy (3-5 year audit plan), maintaining the annual audit schedule
- Responsible for independently leading, planning, audit conduct and reporting of routine and non-routine audits in accordance with the approved schedule
- Maintains responsibility and oversight of audits conducted by PV contractors. This includes identification of suitable PV consultants, setting up contracts and providing training in accordance with company procedures
- Provide advice and support where required in executing CAPAs to ensure compliance to regulatory and Global Quality expectations and requirements. Approves CAPAs and regularly reviews progress and continue to give ongoing support in all compliance matters.
- Contributes to the continuous improvement and maintenance of the GQA and Global QMS by writing SOPs and guidance documents; updating PV report templates and checklists
- Acts as SME for PV compliance by providing advice, and supports sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections) covering inspection preparations, execution, preparation of responses to health authorities and inspection follow-up as well as for key customer audits.
- As required, participates in regulatory inspections in core and supporting roles. Assists with the preparation and delivery of training materials. Advises and contributes to coaching.
- Interprets and applies regulations/ policies to issues of moderate complexity, when required. Provides cross training to other team members in matters of PV.
- Participates in enhancing and maintaining a global platform for sharing Regulatory Inspection deficiencies and "lessons learned" as well as significant customer audit observations to ensure such information is communicated, tracked and responded to accordingly by all GxP sites/entities. Provides relevant audit related information for Management Reviews.
- Maintains / enhances Global Quality audit standard and procedure for harmonised One Audit Process. Provide support and training to all sites, entities for development and enhancement of their Quality Audit governance and procedures. (including self-inspection program).
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Quality Assurance / Quality Systems experience in a GVP environment and or clinical development
- Significant quality experience in the biotechnology or pharmaceutical industries
- Significant PV auditing experience
- Certified Quality auditor
- In depth knowledge of GxP guidance and regulations
- Experience in Regulatory inspections management (MHRA, FDA, EMA)
- Bachelor’s degree in a scientific or health-related field
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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