Computer System Validation Manager
USA Remote /
CompliancePath – Validation Acceleration /
An integral part of Ideagen's wider group, CompliancePath provides remote delivery for software assurance and IT Governance projects.
We are on the lookout for someone who has a technical background in software validation and testing with leadership skills to take on management of a tightly knit global team.
- Work with CompliancePath Head of Validation Acceleration (or deputy) to support validation projects
- Review software systems used in quality processes to determine appropriate validation requirements to meet global GxP regulatory requirements
- Lead Computer System Validation efforts and teams related to authoring and executing specifications and validation documentation for computer systems, in alignment with Good Manufacturing Practices (GMPs)
- Reviews computer system validation documentation, to ensure data integrity requirements are maintained
Skills & Experience
- At least 8 years of experience with software validation, preferably in a GxP environment
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of manufacturing and QC processes and how they relate to regulatory requirements
- Experience testing, and creating validation documents
- Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.)
- Experience in writing and execution of IQ, OQ and PQ for GMP Systems and Software
- Ability to self-motivate and work remotely
- Ability to explain and discuss regulations.
- Ability to manage multiple tasks, in a timely and positive manner
- Willing and able to very occasionally do business travel (including staying away): mainly Barbados, UK, US & EU
- Degree in a science/health-related subject
- Willing to develop an Understanding of EU GDP, EU GMP and Quality Management Systems
- Willing to develop an understanding of local and European regulatory environments
- Good organizational, coordination, diplomatic, negotiation, presentation, and communications skills
- Ambitious - Drive, Planning & Execution
- Adventurous - Flexibility, Resilience & Savvy thinking
- Community - Collaboration & Communication
What's in it for you?
While we take our work and deliverables seriously, we have a relaxed working environment and we want our people to be rewarded for their hard work. We offer benefits such as 34 days' holidays (inclusive of bank holidays), Enhanced Maternity and Paternity Pay, Contributory Pension Scheme, Free On-site Parking, Private Medical Insurance, Free 200degree coffee shop and many more!
Who are Ideagen?
If you have ever flown in a plane, been in hospital, or even given blood, there is a good chance we've helped keep you safe. For nearly a quarter of a century, we have been providing software solutions to thousands of customers such as the UK NHS, Virgin, PwC, Emirates, Heineken and even Harvard University. We are not a large faceless corporation, but we are not a fly-by-night dot com company either. With more than 1150 employees in multiple locations across the UK, USA, Dubai, Malaysia, and Bulgaria – not including our global Partner Network – we're one of the most exciting and fastest growing software companies in the world.