QA Ops & Batch Release Lead

Responsibilities

• Oversee the batch release process to ensure full compliance with regulatory requirements and company standards
• Ensure all activities within the scope of responsibility adhere to Good Manufacturing Practices (GMP) and relevant regulations
• Conduct regular audits of production processes to identify and address potential quality issues
• Collaborate closely with production teams to maintain quality standards throughout the entire product lifecycle
• Manage and resolve quality-related issues, including leading root cause analysis investigations and implementing preventive measures
• Monitor and analyze quality performance metrics and batch release trends to support data-driven decision-making
• Participate in internal and external audits and regulatory inspections by providing necessary support and documentation
• Develop and implement risk management strategies to mitigate potential quality issues during the batch release process
• Coordinate actions across Quality Control and production teams to ensure timely lot release
• Act as the primary contact for on-site complaint investigations within the operations team

Requirements

• Minimum of 2 years of experience in quality assurance within the pharmaceutical industry
• Strong, in-depth knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
• Proven ability to analyze complex data to identify trends, issues, and effective solutions
• High level of accuracy and meticulous attention to detail in all quality assurance activities
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Ability to manage multiple projects simultaneously while adhering to strict quality standards
• Fluency in both the local language and English

About the Company

Sanofi is a global leader in innovative healthcare, dedicated to chasing the miracles of science to improve people's lives. Our Shenzhen site focuses on the end-to-end manufacturing of influenza vaccines and the local packaging of imported vaccines to serve the Chinese market. We foster a culture of excellence, integrity, and continuous improvement, empowering our teams to deliver life-changing medicines to patients worldwide.