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:

Responsibilities
AI-Native Product Strategy for CPV, CMC & APQR

Define and own the product roadmap for AI-powered statistical models embedded within CPV, CMC, and APQR workflows
Drive the strategy for replacing legacy statistical tools with intelligent, in-platform AI capabilities
Identify opportunities to apply generative AI and ML to automate narrative generation, anomaly detection, and predictive batch disposition
Partner with the AI/ML team to align data science capabilities with overall product vision and market differentiation

Statistical & ML Requirements Definition

Translate regulatory and scientific requirements (FDA Process Validation Stage 3, ICH Q10, EMA CMC guidelines) into precise, actionable data science requirements
Define the statistical model selection logic including control charts (Shewhart, CUSUM, EWMA), regression models, PCA, PLS, and multivariate statistical process control (MSPC)
Specify requirements for ML models, including predictive yield models, anomaly detection, and AI-assisted APQR commentary generation
Collaborate with data scientists and ML engineers to define feature engineering, model validation, and explainability requirements for regulated environments
Ensure all statistical and AI features meet 21 CFR Part 11, EU Annex 11, and GAMP 5 compliance requirements

Cross-Functional Collaboration

Work closely with UX/UI designers to translate complex statistical outputs into intuitive dashboards and visualizations for end users
Partner with engineering teams on data pipeline architecture, model deployment patterns, and API design for statistical features
Engage directly with customers, quality directors, validation engineers, data scientists, and regulatory affairs leads to conduct discovery and validate requirements
Serve as the SME bridge between customer-facing teams (Sales, CSM, Professional Services) and product/engineering on all data science-related features

Go-To-Market & Competitive Intelligence

Support product marketing in articulating the differentiation of ValGenesis AI capabilities versus legacy statistical tools and competitor platforms
Track industry trends in AI/ML applications for pharmaceutical manufacturing and quality, including regulatory agency guidance on AI in GxP environments

Required Qualifications:
Education

Bachelor's or Master's degree in Statistics, Biostatistics, Data Science, Chemical Engineering, Pharmaceutical Sciences, or a closely related quantitative field
PhD is a strong plus, particularly in statistics, chemometrics, or pharmaceutical engineering

Domain Expertise

5+ years of hands-on experience in the pharmaceutical or biotech industry in a technical role involving statistical process control, process validation, or quality systems
Deep working knowledge of CPV Stage 3 requirements under FDA's 2011 Process Validation Guidance and ICH Q10
Strong familiarity with CMC data requirements for regulatory submissions (IND, NDA, BLA, CTD Module 3)
Experience authoring or reviewing Annual Product Quality Reviews (APQRs) with statistical components
Understanding of GxP regulatory frameworks: 21 CFR Part 211, 21 CFR Part 11, EU Annex 11, ICH Q8/Q9/Q10

Statistical & AI/ML Skills

Proficiency with statistical methods, including SPC (control charts), process capability indices (Cpk, Ppk), regression analysis, ANOVA, DOE, and multivariate analysis (PCA, PLS, MSPC)
Working knowledge of machine learning techniques: supervised learning (regression, classification), unsupervised learning (clustering, anomaly detection), and time-series forecasting
Familiarity with NLP and generative AI applications particularly for automated report generation and regulatory narrative drafting
Experience with statistical software such as JMP, Minitab, SAS, or R; Python experience (pandas, scikit-learn, statsmodels) is a strong advantage
Understanding of model validation and qualification in regulated GxP environments (GAMP 5 Category 5 software, CSV/CSA requirements)

Product Management Skills

3+ years of product management experience, ideally in life sciences SaaS, regulatory technology, or enterprise data/analytics products
Demonstrated ability to write detailed, unambiguous product requirements documents (PRDs) and user stories for technically complex features
Experience working in Agile/Scrum development environments; proficiency with tools like Jira, Confluence, ProductBoard, or equivalent
Strong analytical thinking with the ability to prioritize competing requirements using data and customer evidence

Preferred Qualifications

Prior experience at a life sciences software company in a product or technical role
Hands-on experience building or specifying AI/ML features for production SaaS products
Knowledge of ISPE PQLI Data Integrity guidance, FDA Computer Software Assurance (CSA) draft guidance, and EU Annex 11 revision (2025 draft)
ASQ Certified Quality Engineer (CQE), Six Sigma Black Belt, or equivalent statistical quality certification
Experience with cloud data platforms (AWS, Azure, GCP) and familiarity with MLOps pipelines
Published papers, conference presentations, or technical writing in pharmaceutical statistics or AI/ML in regulated industries

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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