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Senior Manager, Pharmacogivilance Quality Assurance Oxford United Kingdom,  


Posted on : 26 April 2017

Project Description

The Senior Manager/ Manager of Research and Development Quality Assurance (RDQA) for Pharmacovigilance (PV) is an independent contributor who is responsible for performing quality assurance activities to ensure that the Jazz Global PQS team is adhering to applicable regulations, industry standards, Jazz policies, procedures, and quality standards in support of the Quality Management System. In addition, the Senior Manager/ Manager will support RDQA/ PV leaders in providing strategic input and tactical implementation for pharmacovigilance 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 representing RDQA PV and at times may be asked to perform RDQA activities to support other GxP areas, quality operations, and global quality systems. Essential FunctionsMaintain professional expertise and knowledge of local and international regulations relative to pharmacovigilance and qualitySupport RDQA PV Directors in developing and executing global RDQA PV strategy and implementing associated Quality Management SystemReview internal and external SOPs; and participate in the development of SOPsSupport update of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documentsContribute to the development and implementation of strategic audit plans for pharmacovigilance activities that include service providers, vendors, business partner, and internal audits.Participate in writing Requests for Proposals (RFPs) or Work Orders when engaging with vendors that will be conducting audits on behalf of Jazz; and/or pharmacovigilance agreements (in collaboration with relevant stake holders) when engaging with vendors to perform activities on behalf of Jazz.For pharmacovigilance audits conducted directly by Jazz personnel, or conducted by a vendor on behalf of Jazz (external audits) participate as lead and/or co-auditor and/or oversee and engage 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 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. runner, scribe, backroom lead, SME preparation, etc.)Identify and escalate critical quality issues to senior RDQA managementContribute to the development of continuous quality process improvements and the identification of identifying root causes for investigationsRepresent RDQA within interdepartmental teams / project groupsMaintain current training in accordance with the Jazz RDQA PV training curriculumThis position may require up to 20% travelRequired Knowledge, Skills, and AbilitiesEstablished Pharmacovigilance or Quality professional with proven leadership experience in pharmaceutical, or biotechnology industryStrong GVP/GCP knowledge & expertise;Auditing experience preferredRequired/Preferred Education and LicensesBachelor’s degree in business or life sciences requiredLean Sigma certification preferredRequired CompetenciesExcellent written and verbal communications skillsAbility to work in an entrepreneurial and fast-paced cultureKnowledge of Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP) preferredSelf-directed and ability to take action as needed with limited oversightAbility to collaborate and partner with various internal and external business partnersAbility to work in a team environmentDisciplined, detail orientated, and strong time management skills

Locations

Oxford United Kingdom

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