GVP / GPvP Audit Manager

ProClinical is advertising a vacancy for a GxP Quality Audit Manager position with a leading biotechnology 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. The vacancy offers an impressive salary and the opportunity to work in a home-based capacity.

The GxP Quality Auditor Manager will oversee and execute the global Pharmacovigilance audit activities that serve to periodically monitor compliance of activities surrounding Good Pharmacovigilance Practices (GVP). They will 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.

Job Responsibilities:

• Developing and maintaining the PV high level audit strategy, along with a 3-5-year audit plan.
• Developing the annual audit schedule based on risk assessments and the audit strategy.
• Implementing and maintaining a robust risk assessment process for prioritisation of audits of PV vendors, alliance partners, affiliates, and PV systems.
• 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.
• Independently leading, planning, conducting audits, and reporting routine and non-routine audits in accordance with the approved schedule.
• Delivering audit reports and reviewing CAPA plans in accordance with internal timelines.
• Maintaining the audit database to assist the manager and team with resource planning and KPIs.
• Maintaining responsibility and oversight of audits conducted by PV contractors; identifying suitable PV consultants, setting up contracts, and providing training in accordance with company procedures.
• Contributing to the GQA team by conducting peer review of audit reports conducted by other team members.
• Cooperating with the audited functions to provide advice and support where required in execution of remediation actions (CAPAs) to ensure compliance to regulatory and Global Quality expectations and requirements.
• Approving CAPAs and regularly reviewing progress and continuing to give ongoing support in all compliance matters.
• 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.
• Providing expertise to enhance audit tools and templates in PV.
• Completing all training requirements in a timely manner and maintain personal training records to ensure inspection readiness at all times.
• Participating in regulatory inspections in core and supporting roles.
• Assisting with the preparation and delivery of training materials; advising and contributing to coaching.
• Acting as Subject Matter Expert/Point of Contact to provide expertise and knowledge to less experience auditors, Business Partners, and company entities on quality and compliance processes/procedures.
• Interpreting and applying regulations/policies to issues of moderate complexity, when required.
• Providing cross-training to other team members in matters of PV.
• Maintaining/enhancing Global Quality audit standard and procedure for harmonised One Audit Processes.
• Providing support and training to all sites, entities for development, and enhancement of Quality Audit governance and procedures.

Skills and Requirements:

• A Master's degree in a scientific or health-related field preferred.
• 7-10 years of Quality Assurance/Quality Systems experience in a GVP environment and/or clinical development.
• 5 years of experience in Regulatory Inspections management (MHRA, FFDA, EMA).
• An in-depth knowledge of GxP guidance and regulations.
• 2 years of international travel.
• Certified Quality auditor.
• Demonstrable experience of PV auditing experience.
• An advanced working knowledge and understanding of the application of GxP and GVP to the entire product lifecycle.
• A knowledge of EMA, FDA regulations, and ICH guidelines.
• In-depth understanding and knowledge of oncology and immune-oncology.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

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 Josh Godden at +44 2038540101 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.

#LI-JG1