Manager of Validation and Testing
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Job Summary
To support the evolution of software quality assurance, the full-time Manager of Validation and Testing will lead the transition from manual to automated testing for GxP and non-GxP systems, ensuring compliance with regulatory standards while mentoring a team in a biotechnology research environment.
Key Responsibilities
- Drive the automation transition and modernize testing frameworks for GxP and non-GxP systems
- Oversee risk-based validation and maintain compliance with regulatory guidance, including GxP and ALCOA+
- Lead end-to-end testing processes, ensuring traceability to business and regulatory requirements
Required Qualifications
- Bachelor's Degree
- 8+ years of experience in CSV/software testing, with 5+ years in leadership roles
- Proven background in pharma, biotech, medical devices, or CRO environments
- Hands-on experience with automated testing frameworks and relational databases (SQL Server/Oracle)
- Deep knowledge of ALCOA+, risk-based validation methodologies, and Agile SDLC
Complete Job Description
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