Supply Chain Compliance Manager

Responsibilities

• Oversee and ensure on-site supply chain compliance with local and global regulatory requirements, including GMP, GDP, SOX, and ISO.
• Develop, implement, and maintain supply chain policies, Standard Operating Procedures (SOPs), and related documentation.
• Organize, participate in, and follow up on internal and external supply chain audits and inspections.
• Manage GMP deviations, impact assessments, change controls, and Corrective and Preventive Actions (CAPA).
• Perform root cause analysis to identify and mitigate compliance risks.
• Assist in the validation of new supply chain processes and activities in accordance with GMP guidelines.
• Collaborate with internal partners in Production, Procurement, QC, QA, and Master Data to complete supplier and material certifications.
• Conduct training and awareness programs related to supply chain compliance and GMP processes.
• Track and report on compliance performance metrics, deviations, and changes.
• Coordinate with internal and external partners to resolve logistics complaints and quality events.

Requirements

• Bachelor's degree or higher in Pharmacy, Logistics, Management, or a related field.
• 5+ years of experience in the pharmaceutical industry with direct expertise in GMP and GDP.
• Strong understanding of regulatory and legal requirements within the pharmaceutical sector.
• Excellent data statistical and analytical skills.
• Proficiency in office software and strong logical thinking capabilities.
• Fluent in both Chinese and English (written and verbal).
• Strong teamwork, communication, and problem-solving skills with high professional ethics.

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for patients. We are dedicated to advancing precision medicine and developing transformative treatments through cutting-edge science and innovation.