Director – AI Engineering

ValGenesis · Chennai

About ValGenesis 
ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. 
 
Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.valgenesis.com/about

About the Role:

Key Responsibilities

Technical Capabilities (AI/ML & Data Science)

  • Working understanding of AI/ML concepts (including Generative AI, ML/DL, and statistical approaches) sufficient to engage with customers and interpret solutions developed by engineering teams.
  • Ability to clearly explain AI-driven solutions, their intended use, and limitations in a regulated life sciences context to non-technical stakeholders.
  • Familiarity with AI/ML lifecycle concepts (development, validation, deployment, monitoring), with emphasis on validation and compliance rather than hands-on model development.
  • Understanding of GxP validation principles (e.g., model validation, documentation, traceability, change control) as applied to AI-based systems.
    • Awareness of data integrity principles (e.g., ALCOA+) and their implications for AI solutions in regulated environments.
      • Ability to collaborate effectively with engineering and data science teams, translating technical outputs into customer-ready, compliant narratives.
        • Strong communication skills to bridge technical teams and customer stakeholders, especially during validation reviews and audits

          • AI Governance & Compliance

          • Define and operationalize AI governance frameworks aligned with global regulatory standards (e.g., GxP, HIPAA, GDPR, FDA guidance on AI/ML).
          • Establish policies for model validation, monitoring, explainability, bias mitigation, and auditability.
          • Lead AI risk management processes, including model lifecycle governance and incident response.
          • Partner with legal, regulatory, and quality teams to ensure adherence to evolving AI regulations.
          • Drive internal governance committees and review boards for AI model approvals.

            • Customer Relations & Strategic Engagement

            • Translate complex AI concepts into clear, business-relevant narratives for stakeholders.
            • Lead customer on boarding, adoption, and long-term success strategies.
            • Manage escalations related to AI performance, compliance, or ethical concerns.
            • Gather customer feedback to influence product roadmap and innovation priorities.

              • Thought Leadership & External Representation

              • Represent the company in industry forums, regulatory discussions, and customer workshops.
              • Contribute to whitepapers, audits, and regulatory submissions.
              • Stay ahead of emerging trends in AI regulation and digital health.

Required Qualifications

  • Master’s or PhD in Life Sciences, Computer Science, Data Science, Regulatory Affairs, or related field.
  • 15+ years of experience across AI/ML, life sciences, and customer-facing roles.
  • Strong knowledge of regulated environments (GxP), clinical data, and healthcare compliance frameworks.
  • Proven experience in AI governance, risk management, or responsible AI.
  • Demonstrated success managing enterprise clients in pharma/biotech/healthcare.
  • 10+ years of experience in end-to-end solution delivery, including implementation, deployment, and lifecycle management of AI/analytics solutions.

Preferred Qualifications

  • Experience with AI/ML products in life sciences domain
  • Familiarity with FDA/EMA AI guidance and validation frameworks.
  • Background spanning both technical (AI/ML) and commercial/customer success roles.
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