Head Compliance and Risk Management
Galderma Barcelona
Experteer Overview
As Head of Compliance and Risk Management, you will shape Galderma's global quality and compliance framework across manufacturing, R&D, and supply chains. You will lead a global team, drive regulatory readiness, and embed risk-based governance to safeguard patient safety and product quality.You’ll partner with senior leaders to influence strategic decisions and ensure inspection readiness across regions. This role offers high visibility and tangible impact on the company’s global operations and performance.
Compensaciones / Beneficios- Provide global leadership for GxP compliance, regulatory readiness, and risk management across all functions
- Define and harmonize global policies, procedures, and standards across regions
- Own the global quality risk management framework, including risk registers and governance per ICH Q9
- Lead global audit and inspection readiness, including internal, supplier, and mock inspections
- Oversee readiness for Health Authority inspections (FDA, EMA, MHRA, PMDA, WHO, etc.) and coach SMEs
- Govern deviation, CAPA, and major risk management processes with timely investigations and closure
- Oversee supplier and third-party compliance, audits, and Quality Agreements
- Manage regulatory intelligence and translate changes into actionable plans and training
- Lead digital quality and GxP systems (eQMS, LIMS, LMS, MES, SAP, TrackWise Digital) ensuring data integrity
- Oversee global trade compliance activities and incident management
- Build and develop a high-performing global Compliance & Risk Management team
- Provide data-driven insights on compliance status, risks, and remediation to senior leadership
- 10+ years in pharmaceutical/biotech/medical device with strong GxP, audits, inspections, and quality risk management background
- Proven experience leading global health authority inspections (FDA/EMA)
- Experience operating in global, matrix organizations with dispersed teams
- Strong knowledge of global regulatory environments and quality systems
- Experience with digital quality and data integrity programs, including CSV/CSA and validated GxP systems
- Fluency in English; additional languages advantageous
- Master's degree in a related scientific discipline; advanced degree preferred
- diversity & inclusion
- competitive compensation with bonus
- extended benefit package
- hybrid work culture
- career path with growth opportunities
- ownership and accountability culture
RocheSant Cugat del Vallès, 8 km de Barcelona
or solution. You can read more about the history of mySugr & Roche here.
Here's what we're looking for:
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