Quality Manager, Quality Assurance

Accountabilities

In this role, you will drive quality assurance initiatives, oversee audit programs, and ensure that internal operations and external partnerships meet applicable regulatory standards. Your responsibilities will include:

• Develop and maintain the internal Quality Risk Assessment methodology and a comprehensive Audit Universe.

• Lead Quality Assurance activities related to procurement processes and vendor oversight.

• Establish and manage mechanisms for ongoing compliance monitoring with applicable laws, regulations, and industry standards, including EU GVP, US FDA CFRs, PMDA requirements, and ICH-E6.

• Partner closely with Vendor Management and operational teams to develop and implement risk-based audit strategies.

• Coordinate and contribute to internal system and vendor audits in accordance with the established Audit Plan.

• Manage all pre-audit and post-audit activities, ensuring appropriate documentation, follow-up, and quality control.

• Conduct audits within areas of GxP expertise when required.

• Coordinate audit documentation peer reviews and quality control activities.

• Support client-contracted Quality Assurance services, including audit planning, coordination, and execution.

• Provide GxP Quality Assurance consulting services based on your expertise and professional experience.

• Monitor organizational compliance, identify potential risks at an early stage, and assess their impact on audit strategies, planning, and execution.

• Promote a strong quality culture and act as an ambassador for the Quality Assurance department across the organization.

Requirements:

The ideal candidate is a detail-oriented quality professional with hands-on auditing experience and a solid understanding of clinical research and pharmacovigilance regulations. You should bring:

• A Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences, or another relevant scientific discipline, or an equivalent combination of advanced education and relevant industry experience.

• At least 3 years of direct auditing experience in GCP and/or GVP environments.

• Experience conducting GCP audits, including investigational site, Trial Master File (TMF), and vendor audits, and/or GVP audits involving safety case processing and reporting.

• At least 2 years of experience managing audit programs, including developing and maintaining risk-based audit plans.

• Experience with both GVP and GCP regulatory requirements, or a strong willingness to expand your expertise across both areas.

• Knowledge of relevant regulatory frameworks and quality standards, including ICH-E6, EU GVP, and applicable FDA requirements.

• Strong organizational skills and exceptional attention to detail.

• Excellent communication and facilitation skills, with the ability to collaborate effectively across international teams.

• A proactive, adaptable, and solutions-oriented approach to quality management and regulatory compliance.

• Fluency in English, with the ability to communicate effectively in a global professional environment.

Benefits:

• Opportunity to contribute to clinical research programs focused on rare diseases and oncology.

• Meaningful work supporting the development of safe and effective treatments for patients worldwide.

• Collaboration with an international team of specialists across clinical research, pharmacovigilance, and quality consulting.

• A supportive and collaborative working environment that encourages professional growth and knowledge sharing.

• An inclusive workplace where different perspectives and contributions are valued.

• A culture built around quality, integrity, trust, agility, accountability, and collaborative partnerships.

• Opportunities to take ownership of meaningful projects and make a direct impact on quality standards and patient outcomes.

• Emphasis on flexibility and work-life balance.