AbbVie Senior Manager, Global Safety Compliance in Maidenhead, United Kingdom
We have a newly created role for an experienced PV professional to join our global Affiliate Safety & Compliance Excellence group.
Reporting to the Safety Compliance Director, this key role will focus on holistic (not hands on) CAPA management and regulatory intelligence to enable the team to move to a more advisory function.
Key responsibilities include: * Leading impact assessments and investigations of issues, potential non-conformities, exceptions and CAPAs and proposes solutions to improve the PV quality system and compliance * Tracking, statistical analysis and evaluation of quality data to assimilate trends and improvement recommendations * Participation in internal audits and external inspection activities and facilitating responses with Pharmacovigilance and Patient Safety (PPS) Leadership to ensure complete, compliant, and timely action plan completion * Contributing to impact assessments of changes in worldwide PV regulations and guidelines and making recommendations for process changes in conjunction with groups such as Safety Compliance to ensure compliance * Supporting the collection of PV system performance and compliance metrics to drive continuous improvement actions in response to any issues arising * Responsible for effective, appropriate and up to date PPS procedural documents in support of the PV system * Driving efficiency and consistency of quality through utilization of quality system management practices This is a great opportunity to join an organisation in a role where you can really make an impact.
People. Passion. Possibilities.
In order to be successful in this role you should have / be: * Degree level qualification or equivalent * Proven experience of working with a QMS in PV * Proven experience of managing high level PV CAPA processes * Experience of creating and managing above country processes / improvements * Experience of identifying, implementing and monitoring KPIs and metrics * Able to work independently but can influence stakeholders at senior levels to deliver tangible results and changes * Clear and confident communicator at all levels and across multiple geographies
In return we offer a competitive salary and benefits package includingcar allowance,annual bonus, 25 days holiday, up to 12% employer pension contributions,on-site gym, employee share / save scheme,LTI (stock)anda culture of flexible working / flexible bens.
Job Classification: Experienced
Primary Location: United Kingdom-England-Maidenhead
Organization: Research & Development
Travel: Yes, 10 % of the Time
Req ID: 1704986