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ci/cd gxp automation regulatory compliance ai/ml๐ Description
- Lead design and execution of functional, regression, performance, and AI/ML tests across products.
- Develop scalable automated test frameworks; optimize CI/CD pipelines for efficiency and reliability.
- Embed quality in PDLC/SDLC with cross-functional collaboration.
- Validate AI/ML models, including bias detection, reproducibility, and performance benchmarking.
- Maintain compliance with internal quality systems and external regulatory standards (FDA, ISO); contribute to SOPs and governance.
- Support internal audit readiness and lead preparation for external inspections.
๐ฏ Requirements
- Bachelor's degree and 8+ years of relevant experience in cloud/infrastructure, IT consulting/support, systems administration, or related fields.
- 4-6 years in customer-facing roles and leading projects.
- Strong experience with test automation tools and performance testing.
- Familiarity with regulatory frameworks such as GxP, FDA 21 CFR Part 11, ISO, GDPR.
- Advanced problem-solving and analytical skills; ability to identify root causes and scale solutions.
- Strong written and verbal communication; ability to convey complex technical concepts to diverse audiences; proficient in PM processes.
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