Head Compliance and Risk Management
hace 2 días
Madrid
Overview Job Title: Head of Compliance and Risk Management Location: Barcelona, Spain; Cracow, Poland - Hybrid: 3 days/week onsite The Head of Compliance and Risk Management plays a critical role in shaping Galderma's global quality and compliance landscape. This position offers the opportunity to lead at enterprise level, influencing how compliance, risk management, and regulatory readiness are embedded across a fast-growing, innovation-driven dermatology organisation. As a trusted global leader, you will define and drive Galderma's compliance and risk management strategy, ensuring sustained inspection readiness and consistent adherence to international regulatory standards across all sites and functions. You will work closely with senior leaders, site heads, and cross-functional teams worldwide, providing clear direction, expert guidance, and decisive leadership in complex and high-visibility situations. This role is ideal for an experienced compliance leader who thrives in a global environment, enjoys building strong teams and governance frameworks, and is motivated by making a tangible impact on patient safety, product quality, and business performance. You will have the platform, autonomy, and visibility to shape quality culture, influence strategic decisions, and leave a lasting imprint on Galderma's global operations. 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, implement, and continuously improve global compliance policies, procedures, and standards, ensuring harmonized application across regions and sites. Own the global framework for quality risk management, including the enterprise Quality Risk Register, risk assessment methodologies, mitigation planning, and governance in line with ICH Q9. Lead the global audit and inspection readiness strategy, including internal audits, supplier and third-party audits, mock inspections, and inspection preparedness activities. Oversee global readiness and execution for health authority inspections (FDA, EMA, MHRA, PMDA, WHO, and other authorities), including coaching subject matter experts and senior leadership. Govern global deviation, CAPA, and critical issue management processes, ensuring timely investigation, root cause analysis, effectiveness checks, and appropriate escalation of major risks. Oversee supplier and third-party compliance, including qualification, monitoring, audits, Quality Agreements, and corrective action management. Own regulatory intelligence processes, monitoring global regulatory changes and inspection trends, and translating requirements into actionable business implementation plans and training. Lead compliance strategy for digital quality and GxP systems, including eQMS, LIMS, LMS, MES, SAP, TrackWise Digital, and related platforms, ensuring data integrity, CSV/CSA, and regulatory compliance. Lead global trade compliance activities, including import/export controls, product classification, restricted party screening, and incident management. Build, lead, and develop a high-performing global Compliance & Risk Management team, fostering a culture of accountability, transparency, and continuous improvement. Act as a trusted partner to senior leadership, providing clear, data-driven insights on compliance status, risks, and remediation plans. Skills & Qualifications Master's degree in Pharmacy, Biology, Chemistry, Biotechnology, Engineering, or a related scientific discipline; advanced degree (MBA, MSc, PhD) 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 and managing global health authority inspections, including FDA and EMA; experience with MHRA, PMDA, WHO, or PIC/S is a strong advantage. Demonstrated experience operating in global, matrix organizations and leading geographically dispersed teams. Strong knowledge of global pharmaceutical regulatory environments, quality systems, and compliance governance. Experience overseeing digital quality and data integrity programs, including CSV/CSA, audit trails, and validated GxP systems. Experience working across manufacturing, quality control, supply chain, and/or R&D environments. Strong leadership, influencing, and stakeholder management skills, with the ability to operate credibly at senior and executive levels. Excellent analytical, problem-solving, and decision-making skills, with a proactive and risk-based mindset. Fluency in English; additional languages are an advantage. What we offer in return You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will receive a competitive compensation package with bonus structure and extended benefit package. You will be able to work in a hybrid work culture. You will participate in feedback loops, during which a personalized career path will be established. You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability. Next Steps If your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager. The final step is a panel conversation with the extended team. Our people make a difference At Galderma, youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do. #J-18808-Ljbffr