Senior QA Specialist - Dublin, Ireland - Jazz Pharmaceuticals

Description

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 @JazzPharma on Twitter.

Brief Description:

This role reports to the Quality Systems Process Manager within the Global Quality Systems group, part of the Quality Function, and provides global stewardship and ownership of key elements of the Quality Management System (QMS). Responsible for ownership of assigned QMS process(es), performing key Quality tasks including user training and support of the QMS.

Essential Functions/Responsibilities

The position is responsible for developing and maintaining aspects of the QMS and to ensure that Quality Systems operations are fully in compliance with current international standards for GxP and best practice. The individual is responsible for, but is not limited to, the following:

• Act as Global Process Owner (subject matter expert: SME) and provide guidance, support and oversight for assigned process(es) within the QMS [which currently includes Change Controls, Deviations/CAPAs, Customer/Product Complaints, Document Management, Supplier/Vendor Certification, Audit, and Marketing Authorisation Holder (MAH) Communications].
• Lead Cross Functional Teams to enhance performance and compliance in key elements of the QMS.
• Implement enhancement initiatives through engaging with Global Stakeholders and aligning objectives with Global Departments.
• Assess the effectiveness and efficiency of Quality System processes and support the voice of Global Customers by implementing improvements.
• Is proactive in looking for continuous improvement opportunities within the QMS.
• Develop and present Quality Systems Technical Training to Global users as required.
• Be a key member and/or SME at regulatory or customer audits as required.
• Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.

Required Knowledge, Skills, and Abilities

• Broad experience working in the pharmaceutical sector.
• In-depth knowledge of quality assurance and/or quality systems and procedures as applies across GxP's.
• Very good oral and written communication, interpersonal and professional skills, to interact at all levels including senior executives, contractors, and colleagues.
• Very experienced in data analysis and presentation.
• Thorough understanding of quality systems and GxPs.
• Desirable - competency in using methods and tools to assist production of QMS metrics.
• Desirable – experience as a Lead Auditor; and in Veeva Quality Vault applications especially QualityDocs, and/or the eQMS and/or Risk modules.

Required/Preferred Education and Licenses

• Preferred - Bachelor's degree or a related qualification (required for further career progression).
• Preferred - Lead Auditor qualification or related experience.

Jazz Pharmaceuticals is an Equal Opportunity Employer.