Overview
Manager, Quality and Compliance – FTC Jobs in Cowley – UK at Jazz Pharmaceuticals
Title: Manager, Quality and Compliance – FTC
Company: Jazz Pharmaceuticals
Location: Cowley – UK
Category: Pharmaceutical, Quality Assurance – QA/QC
Position: Manager, Quality and Compliance – 8 months FTC
Location: Cowley
If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose
purpose
is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a
diverse
portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and
innovative
delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @Jazz Pharma on Twitter.
Brief
Description:
The Manager of Quality & Compliance (Q&C) for Pharmacovigilance (PV) is responsible for performing
quality assurance
activities to ensure that Jazz is adhering to Global applicable regulations, industry standards, Jazz policies, procedures and quality standards in support of the Quality Management System within the Research and Development (R&D) Organization.
In addition, the Manager will support Jazz leaders in identifying and
communication
of compliance risks, oversee action plans to mitigate risks (if applicable), and be actively involved in inspections and inspection-readiness activities. This person will participate in interdepartmental teams representing Clinical and PV
Quality Assurance
(CPVQA) and at times may be asked to perform CPVQA activities to support other GxP areas, quality operations, and global quality systems.
Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the development and management of continuous improvements, including the implementation, tracking, maintenance, and effectiveness checking of all PV related activities.
Essential Functions/Responsibilities
• Support the Quality system (eQMS), which includes supporting the management and
Quality Assurance
review and/or approval of Change Controls, Deviations, associated CAPA, extension requests
• Support PV process improvements including review and/or approval of controlled documents, as required, as it relates to
Quality Assurance
activities, meeting with subject matter experts to revise procedures and merge procedures, as part of continuous improvements
• Support the oversight conducted by the Qualified Person for Pharmacovigilance (QPPV) by providing records’ data/information from the eQMS as requested by the Office of the QPPV and as per governing procedural document(s) owned by the Office of QPPV.
• Support timely completion of eQMS records and the progression status of records within the eQMS by conducting follow-up activities and communications with aging/overdue record owners and inform Sr.
Leadership
on a routine basis.
• Assist in inspection related activities, pre, during, and post inspection, such as backroom support and document request
• Assist in developing and monitoring of CAPA from audits an…
