GVP / GPvP Audit Manager

£400.00 - £450 per day
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Posting date: 25 Mar 2019

ProClinical is advertising a vacancy for a GVP/GPvP Audit Manager position with a leading biopharmaceutical company. The organisation specialises in various therapy areas, including oncology, neuroscience, and rare disease fields, and is seeking for a driven individual to join them in a home-based capacity. This is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

  • Developing and maintaining the PV high level audit strategy (3-5 year audit plan).
  • Developing the annual audit schedule based on risk assessments and the audit strategy (3-5-year plan).
  • 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.
  • Leading, planning, conducting audits, and reporting of 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 of and overseeing audits conducted by PV contractors. This includes 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 and providing 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 providing 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 responsible for ongoing maintenance of personal training records to ensure inspection readiness at all times.
  • Acting as SME for PV compliance by providing advice and supporting sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections), covering inspection preparations, executing & preparing responses to health authorities, and inspecting follow-up as well for key customer audits.
  • 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 experienced 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 standards and procedures for harmonised One Audit Process.
  • Providing 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:

  • At least a bachelor's degree in a scientific or health-related field, with a Master's degree preferred.
  • At least 5 years of Quality experience in the biotechnology of pharmaceutical industries.
  • 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.
  • 5 years of experience in Regulatory Inspections Management (MHRA, FDA, EMA).
  • An in-depth knowledge of GxP guidance and regulations.
  • 2 years of International travel.
  • Certification as a Quality auditor.
  • 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 Katty Maia at + 44 2038543317 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.