Experteer Overview
In this role you drive global regulatory compliance and quality operations within GxP environments, partnering with cross-functional teams to enable compliant, scalable business practices. You’ll lead controlled document governance, training governance, and inspection readiness, shaping processes that support safe, effective therapies. This position offers impact across regulatory and quality systems on a global stage, aligning with Parexel’s mission to improve world health. You will work closely with Regulatory Affairs, Quality, CMC, and Clinical Operations to deliver measurable improvements.

Compensaciones / Incentivos
• Serve as SME for controlled document management with governance and inspection readiness
• Create, review, and approve quality documents and procedures per GxP requirements
• Manage document lifecycle including revisions, reviews, and archival
• Support GxP training governance and role-based curricula
• Monitor training compliance and remediation of non-compliant records
• Lead regulatory compliance activities across global GxP operations
• Drive inspection readiness for FDA, EMA, MHRA, and others
• Develop remediation plans for audit findings and compliance gaps




• Manage QMS processes: deviations, CAPAs, change controls, SOPs, document control
• Use metrics to identify compliance risks and drive continuous improvement
• Harmonize quality processes to improve scalability and effectiveness
• Support global compliance initiatives across regions

Responsabilidades
• 8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotech
• Strong knowledge of FDA, EMA, ICH, and global GxP regulations
• Experience supporting regulatory inspections and audit management
• Hands-on experience with controlled document management and eDMS platforms
• Experience with GxP training governance and learning management systems
• Strong analytical, communication, and stakeholder management skills
• Ability to manage multiple priorities in fast-paced environments
• Experience in biologics, vaccines, or advanced therapeutics (preferred)
• Experience supporting global compliance initiatives across multiple regions
• Familiarity with Veeva Vault
• Fluent in English written and spoken

Requisitos principales
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📌 Regulatory Affairs Consultant - Compliance & Process (Multiple Eu locations, home or office based) (Madrid)
🏢 Parexel
📍 Madrid