Digital Quality Systems

3 days ago

Amritsar, Punjab, India beBeeDataGovernance Full time ₹ 1,00,00,000 - ₹ 2,00,00,000
Quality Systems & Data Governance Lead

This role will evolve from overseeing the implementation of our Laboratory Information Management System (LIMS) and its integration with Quality Management Systems (QMS) and NetSuite ERP, into a long-term system owner and custodian of digital quality excellence.

Responsibilities:

  • Digital System Implementation:
    • Lead the selection, design, implementation, validation, deployment, maintenance and support of electronic systems across QA, QC, Production, and Supply Chain (e.g., LIMS, MES, eBMR, ERP, CDS, QMS) across multiple sites.
    • Partner with Production, Engineering, Quality Control (QC), Quality Assurance (QA), IT, and Operations to define user requirements, workflows, and system improvements.
    • Ensure all systems comply with GAMP 5, 21 CFR Part 11, EU Annex 11, and Data Integrity standards.
  • Quality Oversight:
    • Oversee digital workflows, ensuring they align with SOPs, batch records, and regulatory expectations.
    • Monitor and audit electronic data for integrity, traceability, and compliance.
    • Support CAPAs and investigations related to software failures or deviations involving digital systems.
  • Digital Process Improvement:
    • Partner with operations and IT teams to identify process automation opportunities, improve data flow and transparency, and lead adoption of AR/VR across different application areas.
    • Creation of unified data lakes or warehouses.
    • Lead the development of dashboards, analytics tools, and AI/ML-based insights for predictive quality and productivity.
    • Identification and adoption of IoT including sensors, etc. for data collection and processing of information to improve uptimes.
  • Training & Change Management:
    • Lead training initiatives to support software onboarding and proper usage by shop-floor staff.
    • Act as a digital transformation champion, promoting system adoption and reducing manual dependencies.
  • Regulatory Interface:
    • Interface with internal Regulatory Affairs to support submissions, inspections, and responses to queries involving computerised systems.
    • Prepare and participate in regulatory audits (USFDA, EMA, WHO, CDSCO, etc.) related to data management and software validation.

Qualifications & Experience:

  • Bachelor's/Master's in Life Sciences, Computer Science, or Pharmaceutical Sciences.
  • 10+ years industry experience in a GMP-regulated (Pharma/Biotech) environment with experience in LIMS/QMS/ERP systems.
  • Strong understanding of GxP, 21 CFR Part 11, Annex 11, and CSV principles.
  • Proven record of system ownership post-implementation and cross-functional leadership.

Skills & Competencies:

  • Mastery of digital quality systems and data governance.
  • Strong project and change management skills.
  • Excellent communication, leadership, and collaboration abilities.
  • Strong knowledge of laboratory workflows and QC operations.
  • Strong analytical skills and comfort with reporting and dashboards.

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