QMS Supervisor

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.

Job Summary

The QMS Supervisor will provide quality assurance oversight on ISO9001:2015 compliant QMS, ensuring all processes and products adhere to established standards by conducting audit, managing corrective actions (CAPA), investigating non conformances/ Deviations, and collaborating with cross-functional teams to identify and implement process improvements;

Duties/Responsibilities

• Supervise product release program (Production batch records and CofA), ensuring product quality meets specifications and Quality metrics are met (Turnaround Time/On Time Delivery/ Complaint rate);
• Conduct regular production inspections/ GEMBA walks to identify areas of process optimization;
• Investigate non conformances/ customers complaints, root cause analysis, and implement corrective actions. May be required to communicate with external customers;
• Collaborate with production teams to address quality issues and implement corrective actions;
• Maintenance of a document control system. Actively involved in technical documents (SOP/ WI) review and approval;
• Provide training on quality standards, procedures, and methodologies to team members;
• Ensure ongoing maintenance of the QMS, including operations procedures, and other documentation, in compliance with ISO9001:2015;
• Contribute in monitoring and analyzing production and operations quality data to identify trends and potential issues;
• Prepare and present regular quality data to management highlighting key performance indicators (KPIs)
• Participate in risk assessment sessions with operations and back office;
• Archive documents and participate in internal audits and facilitate external audits;
  
  
  

Required Skills/Abilities

• Sound scientific knowledge in manufacturing of GS product;
• Critical thinking and problem solving;
• Data analysis;
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management;
• Continuous improvement mindset;
• Attention to details;
• Strong analytical and problem-solving skills; 
• Excellent communication and interpersonal skills to collaborate with cross-functional teams; 
• Leadership abilities to motivate and develop a quality team;
• Proficient with Microsoft Office Suite or related software;
  
  
  

Education And Experience

• Bachelor's degree in scientific discipline of molecular biology, chemistry, biochemistry, pharmaceutical science, chemical engineering or related field;
• Proven experience in a quality lead role, preferably in a supervisory capacity, in a quality regulated environment;
• Thorough understanding of quality methodologies, including statistical process control (SPC) and root cause analysis;
• Knowledge of relevant industry standards (ISO 9001:2015/ or ISO13485:2016) and regulatory requirements; 
  
  
  

Working Conditions

• Individual may be required to sit, stand, walk regularly in production area, and occasionally lift 0-15 pounds.
  
  
  

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.