GxP Software Quality & Validation Lead | Agile Governance

Discover International

Cape Coral (FL)

In loco

USD 140.000 - 180.000

Tempo pieno

14 giorni+

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Descrizione del lavoro

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.

Competenze

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.

Mansioni

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.