Job
Description
The role of a Manager - Digital Quality Systems & Data Governance is to oversee the implementation of Laboratory Information Management System (LIMS) and its integration with Quality Management Systems (QMS) and NetSuite ERP. The objective is to ensure regulatory compliance, promote adoption, and drive ongoing digital transformation across quality and lab operations. This pivotal role involves managing the lifecycle of quality systems and enhancing efficiency, productivity, and regulatory readiness through cross-functional collaboration with manufacturing, QA/QC, IT, and Regulatory Affairs teams. Key Responsibilities: Software Implementation & Validation: - Lead or support the implementation and validation of electronic systems across QA, QC, Production, and Supply Chain. - Partner with relevant departments to define user requirements, workflows, and system improvements. - Manage configuration changes, upgrades, and enhancement projects in LIMS to ensure compliance with regulatory requirements. - Draft and review documentation such as URS, FDS, IQ/OQ/PQ protocols, traceability matrices, and validation reports. LIMS Management: - Manage the deployment, validation, maintenance, and support of LIMS across multiple laboratory sites. - Partner with Quality Control (QC), Quality Assurance (QA), IT, and Laboratory Operations for system improvements. - 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 to ensure alignment 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. Digital Process Improvement: - 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 for software onboarding and proper usage by shop-floor staff. - Promote system adoption and reduce manual dependencies as a digital transformation champion. Regulatory Interface: - Interface with internal Regulatory Affairs to support submissions, inspections, and responses to queries involving computerised systems. - Prepare and participate in regulatory audits related to data management and software validation. Qualifications & Experience: - Bachelors/Masters in Life Sciences, Computer Science, or Pharmaceutical Sciences. - 10+ years of experience in pharma/biotech industry with expertise in LIMS/QMS/ERP systems in a GMP-regulated environment. - 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,
