Manager - Digital Quality Systems & Data Governance

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. The role will be pivotal in managing the lifecycle of quality systems, ensuring regulatory compliance, promoting adoption, and driving ongoing digital transformation across quality and lab operations.

highly motivated tech-savvy QA Specialist

Reports to:

Key Responsibilities

1. Software Implementation & Validation:

• 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.
• Draft and review documentation such as

  URS

  ,

  FDS

  ,

  IQ/OQ/PQ protocols

  ,

  traceability matrices

  , and

  automated

  validation reports

  .

2. Quality Oversight & Data Integrity:

• 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.

3. Digital Process Improvement and Analytics:

• 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

4. GXP 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.

5. 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.

6. Life Cycle Management:

• Governance of Master Data Management
• Manage configuration changes, upgrades, and enhancement projects in GxP applications
• Manage software vendor relationships, renewals, SLAs, and support issue escalations.
• Optimize licensing and plan budget for system operations and enhancements.

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.