Head Compliance and Risk Management

Galderma

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profile Job Location:

Kraków - Poland

profile Monthly Salary: Not Disclosed
Posted on: 10 hours ago
Vacancies: 1 Vacancy

Job Summary

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.

Job Title: Head of Compliance and Risk Management

Location: Cracow Poland Hybrid: 3 days/week onsite

The Head of Compliance and Risk Management plays a critical role in shaping Galdermas 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 Galdermas 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 Galdermas 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:

  • Masters 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.

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatologic...
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