Laboratory Metrology & Software Systems Supervisor

Position Summary

The Laboratory Metrology & Software Systems Supervisor leads and manages the site laboratory metrology and calibration program and provides oversight of Laboratory Software System Administrators. The role ensures GMP laboratory instruments, measuring devices, reference standards, and laboratory software systems supporting Quality Control (QC) and Analytical Development (AD) remain reliable, controlled, supported, and inspection-ready throughout their lifecycle.

Key Purpose of the Role

• Lead compliant and reliable Laboratory Metrology and Laboratory Software Systems support programs that keep GMP laboratory instruments supporting QC and AD calibrated, qualified, maintained, and fit for intended use while ensuring laboratory software systems are appropriately administered, maintained, and supported.
• Protect the integrity of analytical data, minimize laboratory downtime, support timely laboratory testing and product release activities, and maintain regulatory inspection readiness.

Laboratory Metrology Program Management

• Own and manage the GMP laboratory metrology and calibration program.
• Ensure laboratory instruments are calibrated and maintained within approved intervals and prevent use of instruments with expired, failed, or unacceptable calibration status.
• Maintain the laboratory calibration schedule and ensure calibration procedures, tolerances, ranges, frequencies, and acceptance criteria are appropriate for intended use.
• Ensure calibration records and equipment histories are complete, accurate, traceable, and inspection-ready.

Laboratory Instrument Lifecycle Management

• Support laboratory instruments from introduction and asset registration through qualification, calibration, preventive maintenance, repair, change management, requalification, and retirement.
• Partner with QC, AD, and Validation to establish calibration and qualification requirements before GMP use.
• Assess instrument changes for potential impact to qualification, calibration, analytical methods, and previously generated laboratory data.

Calibration & Preventive Maintenance

• Coordinate laboratory instrument calibration and preventive maintenance activities to minimize disruption to laboratory testing.
• Monitor upcoming and overdue activities, proactively manage risks, and ensure equipment is appropriately returned to GMP service following calibration, maintenance, or repair.
• Review calibration certificates and service documentation for compliance, accuracy, and completeness.

Out-of-Tolerance & Instrument Investigations

• Lead or support investigations involving failed calibrations, out-of-tolerance conditions, and laboratory instrument performance issues.
• Assess potential impact to analytical data, stability results, testing, and product disposition, including the appropriate retrospective impact period.
• Ensure scientifically sound root cause analysis, effective CAPAs, and trending of recurring equipment or calibration failures.
• Escalate significant quality, compliance, data integrity, or business risks to the Quality & Compliance Manager.

Calibration Standards & Traceability

• Manage laboratory reference standards used for calibration and ensure standards remain current, controlled, and appropriately stored.
• Maintain measurement traceability to recognized national or international standards, where applicable.
• Ensure certificates appropriately document calibration status, traceability, and measurement results.

External Service Provider Management

• Coordinate and provide technical oversight of external calibration and laboratory equipment service providers.
• Ensure vendors meet established technical and Quality requirements and review vendor service documentation before equipment is returned to GMP use.
• Monitor vendor quality, turnaround time, responsiveness, and recurring performance issues in partnership with Procurement and Quality.

Laboratory Equipment Governance

• Maintain accurate laboratory equipment master data, including equipment status, calibration and preventive maintenance frequencies, criticality, qualification status, and service history.
• Establish routine governance with QC and AD leadership to review equipment status, upcoming and overdue activities, OOT events, instrument availability, and equipment risks.
• Provide clear metrics and escalation of issues that may impact laboratory testing or product release.

Laboratory Software Systems Administration

• Provide leadership and daily oversight for Software System Administrators supporting GMP laboratory software systems used by QC and AD.
• Ensure user access management activities are performed in accordance with approved procedures and established system roles and responsibilities.
• Oversee routine system maintenance activities to support reliable and compliant operation of laboratory software systems.
• Ensure timely troubleshooting and resolution or escalation of laboratory software system issues to minimize disruption to laboratory testing.
• Coincide with Laboratory Systems / IT, Quality, Validation, vendors, and system owners as needed to support system maintenance and issue resolution.

Quality Systems & Compliance

• Support deviations, investigations, CAPAs, change controls, and Quality Risk Management activities related to laboratory instruments and laboratory software systems.
• Ensure compliance with applicable cGMP requirements, approved procedures, and ALCOA+ data integrity principles for laboratory instruments and laboratory software systems.
• Maintain inspection readiness and serve as a subject matter leader for Laboratory Metrology and Laboratory Software Systems administration during internal, client, and regulatory inspections.

Continuous Improvement

• Trend laboratory equipment performance and identify opportunities to improve reliability and reduce downtime.
• Optimize calibration and preventive maintenance frequencies using documented science- and risk-based approaches.
• Standardize metrology and laboratory software administration procedures, tools, documentation, and digital solutions for scheduling, records, dashboards, access management, maintenance, troubleshooting, and lifecycle management.

Qualifications

• Education: Bachelor's degree in Engineering, Metrology, Chemistry, Life Sciences, Quality, or another relevant technical/scientific discipline preferred. Equivalent technical education and significant relevant experience may be considered.
• Experience: Typically 5+ years of experience in laboratory metrology, calibration, instrumentation, laboratory equipment, Quality, laboratory software systems administration, or a combination of these areas within pharmaceutical, biotechnology, medical device, or another regulated environment, with prior supervisory or technical leadership experience preferred. Experience with GMP calibration programs, equipment lifecycle management, user access management, system maintenance and troubleshooting, investigations, CAPAs, change control, and regulatory inspections is strongly preferred.
• Core Competencies: Laboratory Metrology & Calibration, GMP Laboratory Equipment Lifecycle Management, Measurement Traceability, Out-of-Tolerance Investigations, Laboratory Data Impact Assessment, Root Cause Analysis & CAPA, Quality Risk Management, cGMP & Data Integrity, Equipment Qualification, Technical Problem Solving, People Leadership & Development, Cross-Functional Collaboration, Metrics & Performance Management, Laboratory Software Systems Administration, User Access Management, System Maintenance & Troubleshooting, Regulatory Inspection Readiness.