Proclinical is advertising a vacancy for a GvP/GPvP Audit Manager position with a leading biopharmaceutical company which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity.
Based in Slough, the GxP Quality Auditor Manager role involves managing and executing the global Pharmacovigilance audit activities that serve to periodically monitor compliance of activities surrounding Good Pharmacovigilance Practices (GVP). This role requires strong collaboration with Global Patient Safety key stakeholders, PVQA and the EUQPPV (or deputy) to provide a robust annual audit program based on documented risk assessments.
Job Responsibilities:
- Responsible for the development and ongoing maintenance of the PV high level audit strategy (3-5 year audit plan)
- Responsible for the development of the annual audit schedule based on risk assessments and the audit strategy (3-5-year plan)
- Responsible for implementation and maintenance of a robust risk assessment process for prioritisation of audits of PV vendors, alliance partners, affiliates and PV systems.
- Responsible for performing and documenting risk assessments as a basis for the strategic, tactical and operational planning of pharmacovigilance audit activity by gathering appropriate information from key stakeholders as required
- Responsible for independently leading, planning, audit conduct and reporting of routine and non-routine audits in accordance with the approved schedule.
- Responsible for on time delivery of audit reports and review of CAPA plans in accordance with internal timelines.
- Responsible for maintenance of the audit database to assist the manager and team with resource planning and KPIs
- 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.
- In cooperation with the audited functions, provides advice and support where required in execution of remediation actions (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, checklists and other documents as required and requested by the GQA director.
- Provides expertise to enhance audit tools and templates in PV.
- Completes all training requirements in a timely manner and responsible for ongoing 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)
Skills and Requirements:
- A minimum of a bachelor's degree is required, though a Master's degree in a scientific or health-related field is preferred.
- Minimum of 5 years of Quality experience in the biotechnology or pharmaceutical industries required.
- Demonstrable experience of at least 3 years of PV auditing experience.
- 7-10 Years of Quality Assurance / Quality Systems experience in a GVP environment and or clinical development is preferred.
- 5 Years of Experience in Regulatory inspections management (MHRA, FDA, EMA) is ideal.
- In depth knowledge of GxP guidance and regulations.
- 2 years of International travel is ideal.
- Advanced working knowledge and understanding of the application of GxP and GVP to the entire product lifecycle.
- EMA, FDA regulations and ICH guidelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +442038543317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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