Assistente/Analista de Segurança da Informação focusing on GRC initiatives at AuditSafe in São Paulo. Supporting security controls, risk management, and documentation processes.
About the role
- Lead Compliance and Risk Management at Galderma to ensure quality and regulatory standards. Foster global compliance strategies and team development in a hybrid workspace.
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.
- 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).
- Govern global deviation, CAPA, and critical issue management processes, ensuring timely investigation, root cause analysis, effectiveness checks, and appropriate escalation of major risks.
- Build, lead, and develop a high-performing global Compliance & Risk Management team, fostering a culture of accountability, transparency, and continuous improvement.
Requirements
- 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.
- 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.
- Excellent analytical, problem-solving, and decision-making skills, with a proactive and risk-based mindset.
- Fluency in English; additional languages are an advantage.
Benefits
- competitive compensation package with bonus structure and extended benefit package
- hybrid work culture
- personalized career path establishment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Analyst supporting the execution of PCI DSS compliance controls and procedures at AuditSafe. Collaborating on audits, GAP analyses, and security requirements implementation.
Consultant assisting clients in risk management within Adveez Consulting's IT department. Responsibility for system design, implementation, and compliance monitoring.
Regulatory Affairs Manager coordinating regulatory submissions and compliance for Patient Assistance Programs in Brazil. Collaborating with stakeholders on program execution while ensuring ethical standards.
Regulatory Affairs Manager specializing in food industry compliance across US/North America. Leading regulatory strategies and communication for food ingredients and products.
Compliance Analyst participating in financial compliance processes at Prex. Utilizing data analysis for risk identification and maintaining regulatory compliance.
Control, Risk and Compliance Analyst at Desjardins managing compliance for savings and investment products. Preparing reports and liaising with stakeholders to ensure regulatory compliance and operational risk management.
Senior Manager leading technology - enabled GRC solutions and guiding compliance frameworks. Collaborates with teams to ensure scalable and practical implementations for Crowe's regulatory practices.
Alternant en conformité réglementaire chez Sanofi, contribuant à la conformité mondiale des activités de santé. Collaborant avec une équipe pour développer compétences tout en soutenant l'avenir de la santé.
Environmental Professional ensuring air compliance and permit management for oil and gas operations. Collaborating with teams on compliance, reporting, and regulatory issues across various states.