Manager CPVQA - FTC; Remote Ireland

Position: Manager CPVQA - 1 Year FTC (Remote Ireland)
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit  for more information. Brief

Description:

The Manager, Clinical and Pharmacovigilance Quality Assurance for Pharmacovigilance (PV) system is a significant contributor to Global Quality and is responsible for coordinating activities to regularly verify that Jazz PV system Vendors, commercial partners and Jazz Global R&D/Quality and other teams are operating in line applicable regulations, industry standards, Jazz policies, procedures, and quality standards in support of the Quality Management System & PV system.

In addition, the Manager will support Global Quality/ R&D leaders in providing strategic input and tactical implementation for pharmacovigilance system activities and projects, identify and communicate 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 meetings and at times may be asked to perform activities to support other GxP areas, quality operations, and global quality systems.

Essential Functions Gain and maintain professional expertise and knowledge of local and international regulations relative to pharmacovigilance system and quality Contribute to the execution of Global PV system audit strategy, and implementation within the Quality Management System Perform reviews on internal and external SOPs; participate in the development of SOPs for Quality or PV System stakeholders Support updates of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documents Perform execute and evaluate PV-System auditee risk assessments Coordinate and implement strategic audit plans for pharmacovigilance system activities that include service providers, vendors, business partner, and internal audits.

For pharmacovigilance system audits conducted directly by Jazz personnel or conducted by a vendor on behalf of Jazz (external audits) participate as auditor/co-auditor and/or manage the relationship with the vendor. Present QA findings/observations to in-house staff and, if appropriate, to the responsible service provider, vendor, or partner company. Contribute to the evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement;

ensure adequate and timely closure of CAPAs generated from audits. Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g. inspection readiness training, runner, scribe, backroom lead, SME preparation, QA checks, etc.) Identify and escalate critical quality issues to senior Quality management Contribute to the development of continuous quality process improvements and the identification of identifying root causes for investigations and effectiveness checks if appropriate Represent CPVQA within interdepartmental teams / project groups and innovation projects Maintain current training in accordance with the training curriculum This position may require up to 30% travel Required Knowledge, Skills, and Abilities Established Pharmacovigilance or Quality professional Strong GVP knowledge & expertise Excellent written and verbal communications skills Ability to work in an…