QMS Supervisor

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.