AbbVie Quality Systems Manager, Global Safety Compliance in Maidenhead, United Kingdom

Quality Systems Manager, Global Safety Compliance

United Kingdom, England, Maidenhead

Medical

Requisition #1800291

We have an exciting role in our evolving Global Safety Compliance team for a change orientated, PV expert to support the development, implementation, maintenance and monitoring of an optimized Quality Management System for the AbbVie PPS (Pharmacovigilance and Patient Safety) organization.

Key responsibilities include:

  • Establish and maintain a PV change management process. Drive compliance, usage and SME identification for impact assessments.

  • Manage and monitor the collection of PV system performance and compliance metrics to drive continuous improvement actions in response to any issues arising.

  • Through the tracking, statistical analysis and evaluation of quality data , assimilate trends and provide global improvement recommendations.

  • Leads impact assessments and investigations of issues, potential non-conformities, exceptions and CAPAs and proposes solutions to improve the PV quality system and compliance.

  • Participates in internal audits and external inspection activities and facilitates responses with PPS Leadership to ensure complete, compliant, and timely action plan completion.

  • Evaluates current process for compliance gaps drive gap closure throughout the department by establishing clear and collaborative communications channels.

  • Provides recommendations and action plans to minimise impact of global PV reg changes whilst ensuring compliance. Facilitates department alignment with new legislation.

  • Responsible for the ongoing maintenance and updating of effective, appropriate and up to date PPS procedural documents in support of the PV system.

  • Organizes, authors and maintains quality documentation and strategic mapping of PV Quality Initiatives and directives

Qualifications:

In order to be successful in this role, you should have / be:

  • Bachelor’s Degree or equivalent in related science field

  • Broad PV experience across a range of specialisms

  • Experience of compliance in a PV setting

  • Understanding of the value of a PV Quality Management System

  • Experience of working with global colleagues in a process improvement environment - this does not need to be in a global role but you should have had some above country experience from e.g. project work

  • Ability to function independently, influence a wide range of stakeholders and problem solve effectively

In return we offer a competitive salary and benefits package.