Senior Manager, QA Operations

Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Senior Manager, QA Operations. The Senior Manager, QA Operations is responsible for leading all aspects of the quality operations function, including product release, raw material release, and approval of quality events (e.g. deviations, nonconformances, etc.). This role serves as the senior Quality point of contact for internal and external customers and leads the team, priorities, and resources required to support compliant and timely QA activities. The position ensures compliance with company policies and procedures and applicable domestic and international standards and regulations.

How you will make an impact: 

• Lead the quality operations team for approval and release of finished good products (e.g. critical raw material for further processing, Drug Substances/API's) as needed. 
• Approve master and executed batch records including final product disposition. Review and approve OOS, deviations and nonconformances prior to product release.   
• Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and effectiveness. Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.  
• Review and approve quality agreements, custom product project orders, and other customer contracts containing quality related information. 
• Be the quality point of contact for internal and external customers.
• Lead cross-functional teams in risk identification and mitigation activities during risk management process.
• Lead and/or support external quality audits (e.g. customers, ISO, etc.).  
• Develop, maintain, and communicate quality metrics to ensure visibility of QMS health.  
• Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to develop, implement, and continuously improve the Quality Management System.  
• Manage subordinate employees, including training, employee development, and performance management. 
• Perform other functions and duties as required  

 The skills and experience that you will bring: 

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).  
• Quality professional with a minimum of 10 years relevant experience in a life science industry.  
• Minimum of 5 years of leadership experience.  
• Requires knowledge of ISO 9001 (or ISO 13485) standards and cGMPs regulations (e.g. 21 CFR 210, 211 or 21 CFR 820, ICH Q7). 
• Familiar with cleanroom operations (e.g. operating in a cleanroom, EM monitoring, validation, etc.)  
• Understand Quality Event processes (deviation, non-conformance, OOS, CAPA, etc.)
• Strong and effective verbal and written communication skills.  
• Strong interpersonal, teamwork and customer interfacing skills.  
• Strong problem-solving skills and analytical skills applied to investigations.  
• Self-motivated and able to organize and prioritize multiple tasks.  
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.  
• Experience in supporting inspection readiness activities resulting in successful inspections.  

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