Role Clarity | Operations Manager Laboratory
Department:
Reporting To:
Role Definition:
The Operations Manager Lab Performance is responsible for driving quality governance, audit readiness, operational efficiency, and training compliance in the Central Laboratory. The role ensures that all processes from sample analysis to report delivery align with NABL and internal quality standards. This includes identifying gaps, implementing CAPAs, optimizing workflows, and strengthening team capabilities to ensure timely, error-free diagnostics and continuous process improvement.
Deliverables:
- Achievement of Quality Indicators across Central Lab departments
- Closure of CAPAs with 50% reduction in repeat NCs
- Delivery of error-free reports and within the defined TAT
- Zero major/moderate non-conformities in NABL or external audits
- Capability Building
Task and Activities:
Quality Management & Governance
- Track and analyze daily/monthly Quality Indicators (sample rejection %, rerun %, panic value delays, TAT compliance, QC flags).
- Prepare and share monthly laboratory quality scorecards with the leadership.
- Escalate critical issues (e.g., panic report delays, repeated QC failures) to the Lab Director immediately.
- Conduct weekly Operations huddles with HODs and document action items.
- Identify process gaps in result entry, analyzer performance, and sample flow. Recommend workflow and SOP enhancements.
Quality Monitoring & CAPA Closure
- Record NCs from audits, incident reports, or internal escalations.
- Ensure RCA is initiated within 48 hours and CAPA is implemented with documented closure.
- Track and report CAPA status regularly to ensure no delays in closure.
- Identify repeat NCs and coordinate cross-functional reviews to design preventive system-level interventions.
- Benchmark best practices from other departments or labs and align SOPs accordingly.
Operational Efficiency & Governance
- Monitor analyzer- and test-wise report TAT in real-time using LIMS.
- Identify TAT breaches and follow up on delays (machine downtime, pending validation, resample cases, etc.).
- Coordinate daily with accessioning, processing, and reporting teams to ensure seamless flow of samples and prioritization of urgent/panic tests.
- Perform random report audits for result accuracy and completeness before release.
- Ensure visibility and timely tracking of high-priority samples.
- Investigate and log sample issues (loss, mislabeling, resample) and drive training on error prevention.
- Support resolution of operational disruptions (equipment breakdowns, manpower gaps, high load shifts).
- Supervise real-time lab functioning to ensure SOP compliance and proper manpower deployment across shifts.
Roster & Manpower Management
- Prepare and approve weekly duty rosters with HODs, considering forecasted workload, leaves, and holidays.
- Ensure all departments (Biochemistry, Hematology, Microbiology, etc.) have sufficient and balanced coverage across shifts.
- Track attendance, late coming, and shift handover quality; flag deviations for corrective action.
- Ensure alignment of workforce with high-load and emergency cases as per lab priority.
Stakeholder Management & Communication
- Act as a single point of contact for HODs, Consultants, and Support Functions (Admin, IT, Helpdesk, Logistics).
- Facilitate report clarifications and escalations between consultants and technical teams.
- Share daily dashboards with department headshighlighting key metrics (TAT, QC errors, CAPA progress, etc.).
- Consolidate discussion points from quality and performance meetings for lab-wide alignment.
Audit Compliance & Documentation
- Maintain internal audit calendars and ensure section-wise audits are conducted per schedule.
- Ensure all NABL documentation - SOPs, QC logs, calibration records, reagent tracking, maintenance logs is updated and audit-ready.
- Conduct mock audits to simulate NABL inspections and prepare gap reports.
- Coordinate end-to-end during NABL and external audits, document readiness, team preparation, facility walkthroughs, and response management.
Team Competency & Training Compliance
- Identify team-level skill gaps from audit results, incidents, or feedback.
- Coordinate with L&D for monthly training sessions and ensure attendance and documentation.
- Ensure 100% induction, onboarding, and technical competency assessment for all new joinees within 15 days.
- Track and publish monthly training status reports; escalate gaps to department heads and HR.
