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Head of Compliance and Risk Management

galderma · Barcelona

New
Hybrid Senior 🇬🇧 English
GxP CSV/CSA CAPA Quality Risk Management eQMS LIMS MES SAP TrackWise Digital

Job description

About the role

Galderma is opening a new Global Capability Center in Barcelona to support its global commercial and functional teams. The Head of Compliance and Risk Management leads compliance, risk management and regulatory readiness at enterprise level, working with senior leaders, site heads and cross-functional teams worldwide. The role is based in Barcelona, with a hybrid arrangement of 3 days per week onsite.

Key responsibilities

  • Provide global leadership for GxP compliance, regulatory readiness and risk management across manufacturing, R&D, supply chain, quality control and affiliate operations.
  • Define and improve global compliance policies, procedures and standards, and own the global quality risk management framework (Quality Risk Register, risk assessments, mitigation planning).
  • Lead audit and inspection readiness, including internal audits, supplier and third-party audits, mock inspections and health authority inspections (FDA, EMA, MHRA, PMDA, WHO).
  • Govern deviation, CAPA and critical issue management, and oversee supplier and third-party compliance, including Quality Agreements.
  • Own regulatory intelligence, digital quality and GxP systems (eQMS, LIMS, LMS, MES, SAP, TrackWise Digital), and lead global trade compliance.
  • Build and lead the global Compliance & Risk Management team and advise senior leadership on compliance status and remediation plans.

Required profile

  • Master's degree in Pharmacy, Biology, Chemistry, Biotechnology, Engineering or a related field; advanced degree preferred.
  • 10+ years of experience in pharmaceutical, biotech or medical device environments, with a strong background in GxP compliance, audits, inspections and quality risk management.
  • Proven experience leading global health authority inspections (FDA, EMA); experience with MHRA, PMDA, WHO or PIC/S is an advantage.
  • Experience in global, matrix organisations and leading geographically dispersed teams.
  • Fluency in English; additional languages are an advantage.

Required skills

  • Strong knowledge of global pharmaceutical regulatory environments, quality systems and compliance governance.
  • Digital quality and data integrity programmes (CSV/CSA, audit trails, validated GxP systems).
  • Leadership, influencing and stakeholder management at senior and executive levels.

What we offer

  • Competitive compensation with bonus structure and extended benefits.
  • Hybrid work culture.
  • Personalised career path through feedback loops.

The process starts with a virtual conversation with the recruiter, then with the hiring manager, and ends with a panel with the extended team.

Questions fréquentes

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Source : ats:workday

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Published 14 hours ago

Expires 1 month from now

7 views · 0 interested

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galderma

Barcelona