Descripción del trabajo 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 / Beneficios

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 general 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

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