Head of Digital Manufacturing & Quality

Position: Head of Digital Manufacturing & Quality

Location: Hyderabad
Reporting To: Chief Information & Digital Officer (CIDO)
Department: IT & Digital

Role Overview

The Head of Digital Manufacturing & Quality leads the strategic digital transformation of pharmaceutical manufacturing and quality operations. This role governs the integration and lifecycle management of advanced Manufacturing Execution Systems (MES), Quality Management Systems (QMS including LIMS, LMS, DMS), IT Validation frameworks, Serialization & Track & Trace solutions. The role’s objective is to enable a compliant, connected, and data-driven manufacturing ecosystem aligned with Pharma 4.0 and Industry 4.0 principles, ensuring operational excellence, quality compliance, and regulatory adherence.

Key Responsibilities

• Digital Strategy & Execution:
  Develop and drive a cohesive digital manufacturing and quality roadmap that leverages Pharma 4.0 technologies to enhance operational efficiency, product quality, and regulatory compliance across multiple sites.
• Manufacturing Execution Systems (MES):
  Lead the implementation and integration of MES platforms (e.g., PAS-X) with ERP and L2 automation systems (DCS, PLC, SCADA). Ensure real-time batch control, data capture, and process visibility.
• Quality Systems Management:
  Oversee deployment and optimization of LIMS, QMS, LMS, and DMS platforms to maintain data integrity, regulatory compliance, and continuous quality improvements.
• Shop-Floor Automation Integration:
  Manage integration between MES and industrial automation devices (DCS, PLC, SCADA, BMS, EMS) for seamless data synchronization, process automation, and enhanced operational control.
• Serialization & Track & Trace:
  Own serialization and track & trace platforms including SAP ATTP, Tracelink, and Systech; ensure compliance with global regulations (DSCSA, EU FMD), managing data integration across the supply chain.
• Pharma 4.0 & IIoT Enablement:
  Drive adoption of Industrial IoT, edge computing, AI analytics, digital twins, and smart automation to propel operational intelligence and manufacturing innovation.
• Governance & Risk Management:
  Establish robust governance frameworks covering data integrity, cybersecurity (IT & OT), system change control, and audit trails to uphold compliance and mitigate risks.
• Leadership:
  Build, mentor, and lead cross-functional teams comprising MES, Quality Systems, Serialization, and WMS specialists. Foster a culture of innovation, regulatory compliance, and continuous improvement.

Vendor Management

• Manage partnerships with technology vendors, system integrators, and service providers to ensure timely project delivery, adherence to compliance standards, and alignment with strategic business goals.
• Negotiate contracts and maintain strong vendor relationships to optimize technology investments and support business continuity.

Qualifications & Experience

• Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or related fields; advanced pharmaceutical quality or regulatory certifications preferred.
• 15+ years in pharmaceutical digital manufacturing and quality leadership, with expertise in MES, QMS, Serialization.
• Proven track record of managing multi-site digital transformation projects involving MES, L2 automation integration, quality systems, serialization, and warehouse platforms.
• Deep knowledge of regulatory compliance frameworks including cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11, DSCSA, EU FMD, and data integrity standards.
• Strong leadership, change management, and stakeholder engagement skills with global team management experience.

Core Competencies

• Visionary and strategic leader in Pharma 4.0 and smart manufacturing technologies.
• Comprehensive understanding of pharmaceutical manufacturing, quality, IT, and automation environments.
• Expertise in regulatory requirements, audit readiness, and validation compliance.
• Excellent business acumen with strong analytical and problem-solving capabilities.
• Effective communicator and collaborator skilled in vendor management and cross-functional leadership.
• Ability to balance innovation with operational compliance and stability.