This position is responsible for managing the R&D business requirements for the Quality Management System (QMS). This role is directly responsible to identify, design, implement, and support design capabilities together with providing key support in relation to the technology solution. S/He will deliver QMS business analysis, security, data management, computer system validation and end user training to support the R&D Organization.
- Support Global R&D by assuming primary responsibility as System Administrator for the R&D Quality Management System (QMS) including Deviations, CAPAs, Notice of Events, Change Controls, Audits, Document Management, maintenance of tracking license management and user management, creating user accounts, assigning security profiles, user roles and permission sets.
- Maintain the validated state of the system, troubleshooting and escalating issues that impact expected performance of system. Work cross-functionally with IT and other stakeholders to maintain the system and resolve technical issues.
- Work with the platform vendor to resolve issues while ensuring cost management controls.
- Function as the R&D Quality SME for the management of routine platform upgrades. Assess system upgrades and partner with the Quality Systems team, provide impact assessment to current state and creation of appropriate testing schemes.
- Continuously monitor the performance of the system to ensure it is “fit for purpose”.
- Actively manage system performance on daily basis to ensure maximum action time.
- Support business owners when technical issues arise.
- Monitor user feedback and execute continuous improvement initiatives.
- Implement a Change Advisory Board (CAB) system for enhancements and implement a dashboard of operating the implementation
- Develop and continuously support a “super-User” community within R&D organization
- Train and educate R&D organization staff on how to properly author and manage Deviations (Investigation, Root Cause Analysis, CAPA, Effectiveness Checks)
- Model and encourage adherence to the Jazz Values and Mission.
Required Knowledge, Skills, and Abilities
- Education with a minimum of 8+ years of pharmaceutical experience
- Quality System experience is required
- Proven ability as System Administrator
- Extensive knowledge of ICH Guidelines, FDA and global Regulatory Standards and associated Guidance/Guidelines
- Highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
- Exceptional written and verbal communication skills
Required/Preferred Education and Licenses
- Bachelor’s Degree in Business or Life sciences is preferred; however extensive practical experience is equally important.
- Six Sigma or similar certification is preferred but not required
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Jazz Pharmaceuticals is an Equal Opportunity Employer.