General Manager / DGM / AGM - Digital Enterprise & automation

DEA Job Descriptions

Digital Enterprise & Automation (DEA)

Grade: Vice President | Reports to (TBD): Managing Director / Executive Director

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

Role purpose

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

Core competencies (Includes strategy & governance)

• 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's strategy, roadmap, and budget [PR1] across the five verticals, prioritizing by value delivery to the enterprise, 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, east-west and north-south risk without flattening IT and OT networks into one.
• Ensure GxP risk classification is co-evaluated with Quality and the User Department and built into every URS/DQ; protect/ preserve the independent reporting line of the consolidated Quality & User oversight group
• Lead, develop multi-level resources under the five vertical heads; mitigate key-person risk in a specialist-based model
• Represent DEA at regulatory inspections with audit-read strategies, checks and balances in controls, review and approval authorities including RACI, and independence documentation .
• Sponsor i.DEA Labs and report digital/cyber/OT risk to the Top Management on a defined cadence

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, or direct accountability for both
• 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 (independent oversight), Manufacturing/Engineering, Finance, the five vertical heads/ leads, automation/IT vendors, and Top Management.

AI / Machine Learning

Grade: General Manager / DGM / AGM |

Reports to: Head of Digital Enterprise & Automation| Direct/indirect reports: AI/ML specialists, data engineers, and the i.DEA Labs pool as it relates to AI pilots

Role purpose

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

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 (use-case partnership)
• People leadership (specialist team)

Key responsibilities

• Define and execute the AI/ML roadmap, prioritizing use cases by business relevance, regulatory necessity, operational efficiency 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, including validation, change control, and audit trail
• Create data lakes, source data from LIMS/eQMS/DMS and from 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

• 15+ years in AI/ML or applied data science, with 23 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 honestly to Quality/ Regulatory

Key relationships

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

NOTE: The success of these hired resources, and any other resources planned for hiring subsequently, will hinge entirely on an approved and pre-budgeted roadmap. Adding more people without the required and approved budgets will not allow the company’s digitalisation efforts to scale.

[PR1]To be discussed/ decided