Senior Manager, Global Development Quality Assurance

Responsibilities

• Ensure compliance with local regulations and BNT processes in China
• Support BNT QMS and other global GDQA functions
• Ensure proper assessment of local vendors and support QA to QA relationships with CROs, Labs, and Collaboration Partners
• Provide proactive local GCP compliance, guidance, and advice
• Provide local Clinical QA Compliance, audit, and inspection support, including CAPAs and inspection facilitation
• Provide relevant quality metrics and perform trending of observations and KPIs across auditing activities
• Support the creation and updates of risk-based audit strategies and plans for GCP and GCLP
• Coordinate and oversee audits performed by external vendors and perform audits personally
• Drive risk-based approaches and use critical thinking to solve complex business problems

Requirements

• Advanced academic degree in Life Sciences
• Minimum of 3 years of experience in a Good Clinical Practice (GCP) related environment
• Minimum of 1 year of experience in building and maintaining business partner relations
• Strong knowledge of drug development, clinical development, and research operations
• Expertise in interpreting GCP guidelines for the pharmaceutical industry
• Knowledge of GCP for Labs

Preferred Qualifications

• Experience in Inspection Readiness, Inspection Preparation, and Inspection Management
• Knowledge of process development and industry-standard problem-solving approaches

Benefits

• Competitive remuneration packages determined by role, location, and experience
• A dynamic and diverse workplace that fosters innovation and creativity
• Opportunities to contribute to life-changing medical breakthroughs

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, to improve health worldwide.