Global Head of Laboratory Sciences

Job Title: Global Head Laboratory Sciences
Location: Global / Multi-Site
Reports To: Chief Laboratory Sciences & Operations

Position Overview

The Global Head of Laboratory Sciences is a senior leadership role responsible for the strategic, technical, laboratory operations, and regulatory oversight of a global network of laboratories across multiple continents. These laboratories support clinical development through assay validation and clinical sample analysis. The successful candidate will ensure that all laboratory activities comply with applicable regulatory framework based on clinical endpoints including CAP/CLIA, IVDR, GxP, and relevant international guidelines, and meet the highest standards of technical/scientific rigor, data integrity, and laboratory operational excellence.

Key Responsibilities

Global Leadership & Strategy

• Provide strategic direction and leadership for all laboratory functions across global sites.  Laboratory activities include specialty lab testing using different technological platforms (genomics, molecular testing, virology, flow cytometry, immunoassay, histopathology and other) as well automated analyzers in safety routine testing.  Managing laboratories within Cerba Research and as well oversight of partner lab performance in accordance to terms & conditions established.

• Develop and execute long-term plans for capability growth, platform expansion, and harmonization of laboratory activities.

• Lead and mentor a global team of Heads of Department (HODs) responsible for diverse technological platforms (e.g., genomics, proteomics, cell-based assays, biomarker platforms, and specialty laboratories).

Assay Validation & Sample Analysis

• Oversee end-to-end assay validation for use in clinical trials as well pre-clinical.

• Ensure clinical sample testing supports program needs for clinical endpoints as well CAP/CLIA, IVDR and ISO accreditations.

• Maintain a high standard of data quality, reproducibility, and documentation across all sites.

Regulatory Compliance & Quality Systems

• Ensure all laboratory operations comply with GxP, CAP/CLIA, IVDR, and other regional regulatory requirements as well ISO accreditations.

• Ensure appropriate processes are in place for documenting, investigating, and resolving deviations within required timeframes.

• Lead or oversee root cause analyses (RCA) and corrective/preventive action (CAPA) programs to maintain laboratory operational excellence.

Laboratory Management & Governance

• Harmonize laboratory processes, workflows, and quality standards across global sites.

• Ensure consistent training programs for laboratory personnel, including regulatory and technical competencies.

• Oversee laboratory capacity planning and resource allocation, as well budget oversight.

• Implement robust governance mechanisms for decision-making, risk management, and cross-functional communication.

Forecasting & Capacity Planning Responsibilities

Forecasting, Resource Modelling & Capacity Planning

• Lead global forecasting of laboratory activities, including volume projections for clinical sample analysis, assay validation workload, platform utilization, and operational demands across all sites.

• Develop and implement data-driven models to anticipate future resource needs (FTEs, instrumentation, reagents, digital capacity, and infrastructure).

• Conduct scenario planning to evaluate operational impacts of new clinical programs, expanded assay portfolios, regulatory changes, and shifts in global demand.

• Ensure capacity plans support on-time assay validation, sample testing, and delivery of clinical programs.

• Collaborate with R&D, and Program Management to translate study forecasts and development roadmaps into actionable laboratory capacity requirements.

• Establish governance mechanisms for continuous review of capacity vs. demand and implement corrective actions as needed.

• Present global capacity insights, risks, and mitigation strategies to support strategic planning and investment decisions.

Implementation and Monitoring of KPIs

• Establish, implement, and continuously refine global Key Performance Indicators (KPIs) to measure laboratory performance, quality, compliance and productivity.

• Develop standardized dashboards and reporting mechanisms to ensure real-time visibility of operational metrics across all global sites.

• Monitor KPIs to identify trends, risks, and opportunities for improvement; drive data-based decision-making.

• Ensure KPIs are aligned with regulatory expectations (e.g., CAP/CLIA, IVDR, GxP) and organizational goals.

• Partner with Heads of Department to set target thresholds, track progress, and implement corrective or preventive actions when performance deviates from expectations.

• Present KPI outcomes to Chief Global Laboratory Sciences & Operations, contributing to strategic planning and resource allocation.

Cross-Functional Collaboration

• Work in full collaboration with R&D, Quality Assurance, IT, HR and other inter-departmental support functions

• Serve as a key liaison between laboratories and other business units to harmonize workflows, share data insights, and facilitate decision-making.

Qualifications

• M.Sc or PhD, or equivalent advanced scientific degree in a relevant discipline (e.g., molecular biology, biochemistry, clinical laboratory sciences).

• 8+ years of progressive leadership experience in regulated laboratory environments supporting clinical development.

• Proven experience overseeing assay validation, clinical sample analysis, and laboratory operations under GxP, CAP/CLIA, IVDR, ISO accreditations

• Demonstrated success managing global, multi-disciplinary teams and large-scale laboratory operations.

• Expertise in quality systems, deviation management, RCA, CAPA implementation, and KPI development.

• Excellent communication, stakeholder management, and strategic leadership skills.

• Strong operational & business acumen with the ability to balance innovation, compliance, and efficiency.

Key Competencies

• Global Management & Leadership Skills

• Technical/Scientific and Regulatory Depth

• Quality & Compliance Mindset

• Strategic Planning & Execution

• Operational Excellence

• KPI Development & Performance Monitoring

• Cross-Functional Collaboration & Influence

• People Development & Mentorship

• Risk Management & Decision-Making

Travel

• Travel required (~20–40%) depending on business needs.