Role Description
Job Description Manager - Digital Quality Systems & Data GovernanceThis 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 QA Specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility. This role is pivotal in driving digitalisation 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 Dotted Line Reporting: Chief Information Officer.Key Responsibilities
- Software Implementation & Validation:
- Lead or support the implementation and validation of electronic systems across QA, QC, Production, and Supply Chain (e.g., LIMS, MES, eBMR, ERP, CDS, QMS).
- Lead the deployment, validation, maintenance, and support of LIMS across multiple laboratory sites.
- Partner with Quality Control (QC), Quality Assurance (QA), IT, and Laboratory Operations to define user requirements, workflows, and system improvements.
- Manage configuration changes, upgrades, and enhancement projects in LIMS ensuring compliance with GxP and regulatory requirements.
- 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 validation reports. LIMS Management:
- Lead the deployment, validation, maintenance, and support of LIMS across multiple laboratory sites.
- Partner with Quality Control (QC), Quality Assurance (QA), IT, and Laboratory Operations to define user requirements, workflows, and system improvements.
- Manage configuration changes, upgrades, and enhancement projects in LIMS ensuring compliance with GxP and regulatory requirements.
- Manage software vendor relationships, renewals, SLAs, and support issue escalations.
- Optimize licensing and plan budget for system operations and enhancements.
- 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:
- Partner with operations and IT teams to identify process automation opportunities and improve data flow and transparency.
- Contribute to the development of dashboards, analytics tools, and AI/ML-based insights for predictive quality and productivity.
- 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 in pharma/biotech industry with experience in LIMS/QMS/ERP systems in a GMP-regulated (Pharma/Biotech) environment.
- Experience with LIMS 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 analytical skills and comfort with reporting and dashboards.
- Strong knowledge of laboratory workflows and QC operations.
Skills
Quality Control,Quality Engineering,Lims
