Descripción del trabajoExperteer 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 / BeneficiosServe as SME for controlled document management with governance and inspection readinessCreate, review, and approve quality documents and procedures per GxP requirementsManage document lifecycle including revisions, reviews, and archivalSupport GxP training governance and role-based curriculaMonitor training compliance and remediation of non-compliant recordsLead regulatory compliance activities across global GxP operationsDrive inspection readiness for FDA, EMA, MHRA,



and othersDevelop remediation plans for audit findings and compliance gapsManage QMS processes: deviations, CAPAs, change controls, SOPs, document controlUse metrics to identify compliance risks and drive continuous improvementHarmonize quality processes to improve scalability and effectivenessSupport global compliance initiatives across regionsResponsabilidades8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotechStrong knowledge of FDA, EMA, ICH, and integral GxP regulationsExperience supporting regulatory inspections and audit managementHands‑on experience with controlled document management and eDMS platformsExperience with GxP training governance and learning management systemsStrong analytical, communication, and stakeholder management skillsAbility to manage multiple priorities in fast-paced environmentsExperience in biologics, vaccines, or advanced therapeutics (preferred)Experience supporting global compliance initiatives across multiple regionsFamiliarity with Veeva VaultFluent in English written and spoken#J-18808-Ljbffr

📌 Regulatory Affairs Consultant - Compliance & Process (Multiple Eu Locations, Home Or Office Based) (Madrid)
🏢 Parexel
📍 Madrid