Software Quality & Validation Lead

We’re partnering with a growing pharmaceutical organization in Southwest Florida, on a newly created Software Quality, Validation & Agile Governance Lead position.

This role will take ownership of software quality and validation across a growing portfolio of internally developed GxP systems, helping establish practical, risk-based processes across requirements, testing, validation, change control and software releases.

We’re looking for someone with a strong background in:

• GAMP 5 and 21 CFR Part 11
• Computer System Validation / GxP software validation
• Software quality and release governance
• Change control, requirements and risk assessments
• Improving and streamlining validation processes in regulated environments
• Working cross-functionally with Software, IT, QA and business stakeholders
• 8-10+ years of relevant experience
• Pharmaceutical, biotech, medical device or other regulated industry backgrounds considered

Experience with Azure DevOps, Agile environments and modern web applications would be

beneficial, but is not essential.

If you have built or improved software quality / CSV processes rather than simply executed validation protocols, I’d be particularly interested in speaking.

Please apply directly or message me for more information.