Manager, IT Applications

Corporate   ·      Dublin / Oxford     ·       Full time

• Multiple Locations: Dublin, Ireland; Oxford, United Kingdom
• Categories: Corporate
• Req ID: 10405

Job Description

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 www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.

In this hands-on role, this person will be responsible for collaborating with Quality, Technical Operations & Manufacturing, Finance, Learning and Development (L&D) and other Jazz functions to manage, improve and support business capabilities for Quality Management Systems, together with providing key tier 2 support in relation to the technology systems which enable these functions. This person will deliver business analysis, security, data management, and computer system validation activities which adhere to Jazz’ policies, SOP’s and best practices for GxP and Non-GxP systems to support all aspects of the organization’s operations. The role incorporates (but is not limited to) system ownership for a number of key Jazz Global Quality Management applications, such as Veeva Quality Vault and JazzLearn (Jazz’s primary learning management system supporting GxP training)

Essential Functions

• Work collaboratively with IT teams, internal business partners and external vendors to identify, understand, implement and support new business capabilities where appropriate.
• support and continuously improve the operating model for Jazz quality systems.
• Support the implementation process and/or system changes that improve the effectiveness of business areas.
• Provide level 2 Support for the Quality Management systems.
• Maintain a productive and collaborative partnership with manage service providers.
• Reporting, processing and resolving any incidents & requests reported by end users in accordance with Jazz standard processes.
• Liaise with the 3rd party vendor’s Technical Support team(s) to determine and implement incident resolution in a timely manner.
• Support the implementation of process improvements / configuration changes identified by the business in accordance with Jazz standard Change Control processes.
• Coordinate the implementation of Patches / Upgrades etc. with the vendor to minimize impact to ongoing projects and resources. Ensure proper testing and communications are conducted.
• Collaborate with Digital QA, IS Compliance, and business functions to ensure successful planning, execution and delivery of validation projects following the Jazz CSA framework, methodology, and procedures.
• Collaborate to support validation test protocols, such as IQ/OQ/PQ, in accordance with the validation master plan and other applicable standard operating procedures (SOPs).
• Work collaboratively with other System owners, Jazz Digital QA and IS Compliance to ensure that GxP systems are operating as expected and are maintained in accordance with regulatory requirements and Jazz SOPs
• Work with IS Business Partners, Business Process Owners and Change Boards/Governance Councils to identify and prioritize any process / system enhancements, working with Jazz internal teams to ensure timely implementation
• Ensure that the learning management system (LMS) meets all regulatory compliance needs and ensure data accuracy and integrity
• Monitor the Service Level Agreement and Quality Technical Agreement with the system Vendors
• Collaborating with external partners (MSPs) as a cross-functional team to ensure compliance and operational effectiveness of quality systems support Jazz 
• Work directly with System, Business Administrators and SuperUsers to ensure compliance and productive working relationships.
• Assist with troubleshooting quality / functionality issues associated with the systems
• Maintain a positive and collaborating working relationship with the system vendors
• Foster a positive employee relations environment and a culture of continuous improvement, partnership, and teamwork through the use of good and consistent management principles.

Required Knowledge, Skills, and Abilities

• experience of, QMS systems and processes, including CAPA/Deviation, Product Complaints, Audit, Document Control and Change Management.  Knowledge of Veeva Systems an advantage.
• Knowledge of Pharmaceutical Quality Systems, Computer system/software validation, agile Software Development Life Cycle (SDLC) Management methodologies and ITIL service management framework. 
• Instils an agile and continuous improvement culture.
• Knowledge of LMS particularly in the Pharma industry. 
• Able to work independently as well as with global crisscross-functionalism and time zones made of internal customers and external service providers
• Highly or organized with exceptional time management and prioritization skills
• Excellent verbal and written communication skills
• Patient and results orientated
• Highly motivated
• Collaborative team player
• Strong work ethic with a flexible and adaptable approach

Required Education and Experience

• Bachelor’s degree in Science, Computer Science or equivalent experience required.
• Experience (3+ years) working in support of enterprise-wide systems in a Business analyst and/or Technical  role, with implementation and operations support experience

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Please click here to apply.