- Company Name
- Cerba Research
- Job Title
- Global Head of Operations
- Job Description
-
**Job Title**
Global Head of Operations
**Role Summary**
Strategic leader responsible for end‑to‑end management of clinical sample handling, kit assembly, and global logistics for clinical trials. Ensures compliance with international regulatory frameworks (FDA, EMA, MHRA, IATA, ISO) and drives operational excellence across multi‑country sites.
**Expectations**
- Lead global operational strategy and execution for sample lifecycle and kit logistics.
- Deliver compliant, efficient, and scalable processes that protect patient safety and data integrity.
- Set and monitor KPIs, drive continuous improvement, and maintain audit‑ready operations.
**Key Responsibilities**
- Develop and implement global strategies for biological sample management, clinical kit production, and logistics.
- Standardise processes across international sites; promote continuous improvement and cross‑functional collaboration.
- Oversee receipt, accessioning, storage, and shipment of clinical samples; maintain chain of custody and regulatory compliance.
- Manage kit assembly: sourcing, component QC, labeling, packaging, and IATA‑compliant logistics.
- Lead global logistics strategy; ensure compliance with IATA Dangerous Goods Regulations and regional transport requirements.
- Maintain regulatory compliance with GCP, GLP, GDP, IATA, ISO 9001/17025/15189/13485, CLIA, CAP, GAP IV, and FDA/EMA/MHRA.
- Design, implement, and audit internal QA/QC systems; collaborate with QA on audits, CAPAs, and inspection readiness.
- Ensure trade compliance and customs regulation adherence; manage import permits for APAC and other markets.
- Lead internal audits, CAPAs, training, and vendor management.
- Set and monitor KPIs (shipment compliance, permit compliance, documentation deviations, trade penalties, audit completion).
- Lead a globally distributed operations team; foster high‑performance culture, succession planning, and training.
- Forecast operations budgets, manage cost controls, and evaluate third‑party vendors.
- Contribute operational insights for business development, proposals, and bid defense.
**Required Skills**
- Strategic planning & execution in clinical operations.
- Deep knowledge of GCP, GLP, GDP, IATA, ISO standards, and global regulatory compliance.
- Expertise in global logistics and clinical kit lifecycle management.
- Proficiency in trade compliance, import/export processes, and APAC market regulations.
- Strong audit management, CAPA implementation, and quality system design.
- Leadership of distributed teams across multiple time zones.
- KPI development, performance monitoring, and continuous improvement.
- Vendor selection, performance monitoring, and cost‑control.
- Excellent communication, stakeholder management, and cross‑functional collaboration.
**Required Education & Certifications**
- Bachelor’s degree in Life Sciences, Logistics, Supply Chain, or related field (Master’s preferred).
- 10+ years’ experience in clinical operations or laboratory services; background in CRO, pharmaceuticals, or clinical diagnostics.
- Certifications/qualifications: GCP/IP, ISO 9001/17025/15189/13485 knowledge; additional training in trade compliance, IATA Dangerous Goods, and regulatory affairs is highly valued.