Digital Enterprise & Automation (DEA)

Grade: Vice President | Reports to: Managing Director / Executive Director

Direct reports: GM Level for IT, Automation and AI/ML; Senior Manager - BMS/IoT, Business Process Mapping & Analytics

Role purpose:

Own the strategy, execution, governance, and performance of the company's converged digital and automation estate, preserving the GxP rigor, segregation of duties, and patient-safety assurance a vaccine manufacturer requires.

Core competencies:

- IT infrastructure

- Enterprise applications

- Automation / OT integration

- Building monitoring systems & IoT

- Business process mapping & analytics

- AI/ML strategy & governance

- GxP/regulatory compliance & audit readiness

- People leadership & stakeholder management

Key responsibilities:

- Own DEA strategy, roadmap, and budget across five verticals, prioritizing by value delivery, digitalization impact, regulatory necessity, and ROI

- Drive Harmonization Council: standardize vendors and technology stacks to build specialist depth and cross-facility interoperability

- Own converged IT/OT cybersecurity governance - micro-segmentation, RTO/RPO, and risk management without flattening IT and OT networks

- Ensure GxP risk classification is co-evaluated with Quality and the User Department and built into every URS/DQ

- Lead and develop multi-level resources under the five vertical heads; mitigate key-person risk

- Represent DEA at regulatory inspections with audit-read strategies and defined controls

- Sponsor i.DEA Labs and report digital/cyber/OT risk to Top Management

Qualifications:

- 20+ years in IT and/or automation leadership, including 10+ years in regulated manufacturing (pharma/biologics/vaccines preferred)

- Experience leading both enterprise IT and industrial automation/OT

- Working knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, WHO TRS, ICH, and CDSCO Schedule M

- Experience with IT/OT cybersecurity architecture and multi-site vendor/technology standardization

Key relationships:

Quality & Regulatory, Manufacturing/Engineering, Finance, vertical heads, automation/IT vendors, and Top Management.

AI / Machine Learning

Grade: General Manager / DGM / AGM

Reports to: Head of Digital Enterprise & Automation

Role purpose:

Build and lead the AI/ML practice serving use cases from IT, Automation, BMS/IoT, and Business Process Mapping groups, ensuring GxP-impacting models carry proper validation and Quality sign-off.

Core competencies:

- AI/ML strategy & governance

- GxP/regulatory compliance as applicable to AI/ML systems

- Data integration across IT, automation and OT sources

- Business process mapping & analytics

- People leadership

Key responsibilities:

- Define and execute the AI/ML roadmap, prioritizing use cases by business relevance, regulatory necessity, and ROI

- Own the local AI/LLM infrastructure and RAG/knowledge-assistant architecture for GxP regulatory and quality use cases

- Establish a non-negotiable Quality/Regulatory sign-off pathway for any model feeding a GxP decision

- Create data lakes, source data from LIMS/eQMS/DMS and historian/SCADA/sensor systems without breaching IT/OT network segmentation

- Maintain model and data lineage documentation sufficient for regulatory inspection

- Report AI program status, risk, and value to the Head of DEA

Qualifications:

- 10+ years in AI/ML or applied data science, with 2-3 years in a regulated industry preferred

- Hands-on experience building and deploying LLM/RAG systems, including on-premises inference

- Working familiarity with GAMP 5 and 21 CFR Part 11 as applied to AI/ML systems

- Experience integrating enterprise IT data (ERP, LIMS, eQMS, etc.) with OT data (historians, SCADA, etc.)

- Ability to lead a small technical team and communicate model limitations to Quality/Regulatory

Key relationships:

Head of DEA, Quality & Regulatory, IT Applications and Automation GMs, Business Process Mapping & Analytics, and i.DEA Labs.