Descripción del trabajo
Position : Global Clinical Quality Specialist
Location : Madrid - 4 days onsite / 1 day from home.
As a Global Clinical Quality Specialist (GCP Auditor), you will lead the creation, implementation, and monitoring of standard operating procedures (SOPs), manuals, and internal controls within the Clinical Operations (Clin Ops) team. Your role will ensure compliance with regulatory, internal, and industry standards while fostering efficiency and continuous improvement.
Key Responsibilities :
* SOP & Procedure Management : Develop, implement, and maintain SOPs aligned with regulatory and industry standards.
* Compliance & Internal Controls : Establish periodic internal controls to ensure adherence to procedures.
* CAPA Oversight : Manage Corrective and Preventive Actions (CAPAs) from audits and regulatory inspections, ensuring timely follow-ups.
* Audit & Inspection Support : Provide end-to-end support during regulatory inspections and audits.
* Training & Development : Design and implement training programs to keep staff updated on regulations and compliance.
* Regulatory Monitoring : Stay informed on legislative and regulatory updates impacting global clinical operations and update SOPs accordingly.
* Risk Management : Collaborate with clinical project managers to develop risk assessment plans.
* Process Standardization : Ensure consistency in Clin Ops plans, manuals, and procedures while providing guidance on quality assurance matters.
* Quality Management Plan (QMP) : Develop and customize a QMP template per study requirements.
* Metrics & KPIs Development : Define and track Clin Ops QA metrics and key performance indicators.
* Document Maintenance : Ensure all necessary documentation is up-to-date and compliant with organizational policies.
What You Need :
* Education : Degree in Health Sciences (e.g., Chemistry, Pharmacy, Biology, Medicine) with expertise in clinical operations, quality, and GxP. A Master’s degree is a plus.
* Languages : Fluent in Spanish and English; additional languages are an asset.
* Experience : Minimum 2 years in quality assurance roles within the pharmaceutical sector, plus at least 1 year in clinical operations.
* Expertise : Strong knowledge of international regulations and hands-on experience in SOP development.
* Skills : Proactive, adaptable, strategic thinker with excellent organizational and communication abilities. Ability to work in a global, multicultural setting and train multidisciplinary teams.
* Travel : Willingness to travel up to 30%.
Our Benefits :
* Flexible start time (Monday to Friday, full-time 40 hours)
* Permanent contract
* Competitive salary package
* Life and accident insurance
* Meal vouchers
* Co-payment options for voluntary health insurance
* Employee benefits and savings programs
* Company parking
* Career development and internal mobility opportunities
* And much more!
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