IT Product Manager, Quality Systems
- Cork
- Permanent
- Full-time
- Proven experience in managing stakeholders and demonstrates ability to navigate a complex business environment.
- Deep understand of the current and developing IT Arena, specifically digitisation, cloud and cyber security.
- Initial focus is to lead remediation & upgrade projects on legacy systems to bring in-line with current technologies.
- Projects will be across QA, QC, Production Quality Systems and Supply Chain functions.
- Other projects will cover migrations, New Technology introduction, Cyber Risks and Application risk analysis.
- You will work with and be supported by other teams in the organisation including high level IT Architecture Team, Cyber Security, Technical Support etc.
- A Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math) or equivalent
- Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain
- Technical experience with Quality platforms such as, but not limited to - LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower) , Environmental Monitoring, Quality Management systems is Mandatory.
- Expert understanding of analysis & design and system architecture concepts.
- Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11.
- Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.
- Expert understanding of the Lab business processes, drug development experience an advantage
- Ability to break down problems, build requirements for development tasks in an agile manner.