Quality Manager, Quality Assurance

📋 Description

• Develops and maintains the internal Quality Risk Assessment methodology
• Develops and maintains a comprehensive Audit Universe
• Leads Quality Assurance activities in relation to procurement and vendor oversight
• Monitors compliance within the organization to ensure early identification and review its impact on
• Coordinates and contributes to internal system and/or vendor audits initiated by the Company
• Conducts audits or coordinates audit documentation peer review and quality control activities

🎯 Requirements

• Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences, or another
• Experience with both GVP and GCP regulatory requirements, or willingness to broaden expertise
• At least 3 years of direct auditing experience in GCP (e.g., investigational sites, TMFs, Vendors)
• At least 2 years of experience in audit program management including development and maintenance of
• Organization skills, attention to details, excellent communication and facilitation skills within a
• Proactive, fluent in English

🎁 Benefits

• Work with purpose and make a difference by helping to bring safe and effective pharmaceutical
• Collaborative and passionate team of experts in clinical research, pharmacovigilance, and quality
• Agility to make an impact and work-life balance
• Culture values: Quality, Integrity and trust, Drive and passion, Agility and responsiveness
• Opportunity to work in a global company with presence across North America, South America, Europe