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.

We are seeking a highly motivated tech-savvy QA Specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility.

This role is pivotal in driving digitalization across Quality Control (QC), Production, and QA operations, ensuring seamless data collection, validation, software adoption, and system compliance.

The ideal candidate will work cross-functionally with manufacturing, QA/QC, IT, and Regulatory Affairs to enhance efficiency, productivity, and regulatory readiness.

Reports to: Head - Quality Assurance.

Key Responsibilities:

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.

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.

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.

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.

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.

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.