Global Head of Operations

Global Head of Operations

Department:

Laboratory & Operations

Reports To:

Global laboratory & Operations Officer

Location:

Global / Remote with International Travel

Position Summary:

We are seeking a strategic and experienced leader to serve as the Global Head of Operations overseeing sample handling, clinical kit building, and logistics/transportation services. This role will lead global operations to support clinical research trials by ensuring efficiency, quality, with particular emphasis on global regulatory compliance across all workflows related to clinical samples from patients enrolled in the clinical trial and materials for patients sampling. The position requires deep, demonstrable expertise in navigating international regulatory frameworks (e.g., FDA, EMA, MHRA, IATA, ISO standards) to safeguard patient safety, data integrity, and trial validity.

Key Responsibilities:

Strategic & Operational Leadership

• Develop and implement global strategies for biological sample lifecycle management, clinical kit production and logistics.

• Standardize operational processes across highly complex, multi-country operations and sites to drive efficiency, scalability, and compliance with proven track record in implementing global standards.

• Promote a culture of continuous improvement, innovation, and cross-functional collaboration.

Sample & Kit Handling

• Oversee end-to-end processes for receipt, accessioning, storage, and outbound shipment of clinical samples.

• Ensure proper chain of custody and adherence to regulatory requirements and accreditations as described in section Compliance & Quality

• Manage global clinical kit assembly, including sourcing, component QC, labeling, and packaging compliance.

Logistics & Transportation

• Lead strategy and execution of global logistics, including time-sensitive shipments.

• Ensure full compliance with IATA Dangerous Goods Regulations and regional transport requirements.

• Manage relationships with courier partners, and customs brokers.

Compliance & Quality

• Ensure operations comply with:

  • GCP, GLP, GDP

  • IATA regulations for biological specimens

  • ISO 9001, ISO 17025, ISO 15189, ISO 13485, CAP, CLIA, GAP IV and others where applicable

  • US FDA, EMA, MHRA, and global regulatory authorities

• Design, implement, and continuously audit internal QA/QC systems to prevent documentation errors, non-compliance, or operational delays.

• Collaborate with QA and Operational teams to manage audits, QE, CAPAs, and inspection readiness.

Trade Compliance & Risk Management

• Ensure full compliance with global trade laws and customs regulations  

• Demonstrated expertise in import permit processes, especially in APAC markets (e.g., China, India, Japan, Australia, South Korea) and other regulated regions.

• Oversee accurate kit documentation and labeling, ensuring:

  • Full alignment between kit contents and component lists

• Partner with legal to monitor evolving global requirements and update SOPs accordingly; requiring advanced knowledge of international regulatory landscapes and the ability to proactively adapt operations.

• Conduct routine internal audits, lead CAPAs, and ensure training of internal teams and third-party vendors.

Key Performance Indicators (KPIs):

• Implement KPI to monitor different aspects of the Operations, such as but not limited to: 

  • shipment compliance rate (no customs hold due to errors)

  • permit compliance for regulated jurisdictions

o   Documentation deviation rate per audit

• response time for trade compliance issues

• trade-related regulatory penalties annually

• quarterly audit completion rate for high-risk areas

Team Leadership & Development

• Lead a globally distributed operations team across multiple time zones and facilities.

• Foster a high-performance culture centered on accountability, transparency, and operational excellence.

• Drive talent development, succession planning, and operational training programs.

Financial & Vendor Management

• Develop and manage operational forecasting activities and cost-control initiatives.

• Oversee third-party vendor selection, and performance monitoring.

• Support business development through operational strategy input for proposals and bid defense meetings.

Qualifications:

Education & Experience

• Bachelor’s degree in Life Sciences, Logistics, Supply Chain, or related field (Master’s preferred)

• 10+ years in clinical operations or laboratory services

• Strong background in CRO, pharmaceutical, or clinical diagnostics industry

Technical & Regulatory Expertise

• In depth, hands-on expertise with GCP, GLP, GDP, IATA, ISO, CAP, CLIA and specialist-level understanding of international trade compliance regulations and their practical application in clinical operations

• Proven experience with global logistics operations and clinical kit lifecycle

• Familiarity with import/export processes, permits, and documentation requirements for APAC and other international markets

Leadership & Communication

• Strong leadership, cross-functional coordination, and strategic communication skills

• Proven ability to lead change and scale operations in dynamic, highly regulated environments with a proven track record of leading global transformation projects and delivering operational excellence under strict regulatory oversight