Software Quality & Validation Lead

Discover International; Cape Coral (FL); On-site; USD 140,000 - 180,000; Full time

Job summary

Discover International in Southwest Florida seeks a Software Quality, Validation & Agile Governance Lead to own software quality and validation across GxP systems, drive risk-based processes for requirements, testing, validation, change control and releases.

Candidates should have 8-10+ years in regulated industries such as pharma/biotech, familiarity with GAMP 5 and 21 CFR Part 11, and experience with Azure DevOps and Agile environments; strong cross-functional collaboration is essential.

Qualifications

• 8–10+ years of experience in regulated environments.
• Strong background in GAMP 5 and 21 CFR Part 11.
• Experience with software quality, validation and governance.
• Proven change control, requirements and risk assessment skills.
• Ability to streamline validation processes.

Responsibilities

• Own software quality and CSV across GxP systems.
• Establish risk-based processes for requirements, testing, validation and releases.
• Lead changes, audits and software release governance.
• Collaborate across Software, IT, QA and business stakeholders.

Skills

GAMP 5

21 CFR Part 11

CSV / GxP validation

Software quality governance

Release governance

Change control

Requirements & risk assessments

Process improvement

Cross-functional collaboration

8-10+ years experience

Tools

Azure DevOps

Job description

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.