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