The Director of AI Engineering will oversee product delivery, manage AI solutions deployment, ensure compliance with regulations, and lead customer engagement, requiring extensive experience in AI and life sciences.
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
- 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
- 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.
- 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.
- 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.
Technical Capabilities (AI/ML & Data Science)
AI Governance & Compliance
Customer Relations & Strategic Engagement
Thought Leadership & External Representation
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.
We’re on a Mission
In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard.
Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.
The Team You’ll Join
Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission.
We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.
We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.
We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader.
How We Work
Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company.
ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.
ValGenesis Chennai, Tamil Nadu, IND Office
C S I R Road, Taramani, 705-708, 7th Floor, Phase II, TICEL BIO Park Limited, , Chennai, Tamil Nadu, India, 600113
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