Manager, Quality Assurance

Company: Fusion Health
Location: Redwood City
Posted on: May 24, 2023

Job Description:

The Manager/Sr. Manager, QA will support the company's Quality Assurance program. - The Manager/Sr. Manager, QA will provide quality oversight and CMO management to assure cGMP compliance and product quality. - The Manager/Sr. Manager, QA is responsible for leading GMP quality operations and Quality Systems to ensure the timely resolution of quality related matters, product disposition, and the review/approval of CMO documentation to assure compliance to internal procedures, appropriate cGMP regulations, and established quality agreements. - The Manager/Sr. Manager, QA is also responsible for quality operational support as it pertains to Document Management, GxP Training and records management as well as providing leadership with the implementation of Quality Systems. The Manager/Sr. Manager, QA also plays a key role in inspection preparation and management.
Essential Responsibilities:

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• Review manufacturing batch records and QC data and commercial products to ensure CMO manufacturing and analytical testing are performed in accordance with applicable company procedures and are in compliance with all applicable regulatory requirements; disposition product lots per company procedures.
  
• Resolve CMO quality deviations and investigations and assure appropriate CAPA defined.
  
  
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  • Review and approve CMO quality records (e.g., change control, protocols, reports, specifications, methods, et.) to assure documentation is scientifically sound and justified, where appropriate and meets cGMP and other applicable regulatory requirements.
    
  • Attend project meetings and on-site visits (where appropriate) and provide quality and compliance guidance; prepare and present quality updates at internal company meetings.
    
  • Support and/or perform quality audits or technical visits of CMO according to established audit schedule or project objectives.
    
  • Establish or support the implementation of procedures and polies to support Quality operations.
    
  • Establish and maintain CMO metrics.
    
    
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    • Participates in the preparation and review of regulatory submission documents, and company abstracts pertaining to the GMP manufacture of products
      
    • Leads inspection readiness activities and participates in inspection hosting activities.
      
    • Coordinate responses to regulatory agency inspections and support remediation of identified gaps to assure cGMP compliance and PAI readiness.
      
    • Manages qualification of GxP vendors
      
    • Manages GxP audit and qualification documentation and records
      
      
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      • Provide supervision, guidance, and leadership to junior Quality Team members
        
        Education and Experience Requirements:
        
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        • B.S./M.S. in relevant science field.
          
          
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          • 7+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems.
            
          • Demonstrated working knowledge and compliance experience on cGMP requirements.
            
          • Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing cGMP operations.
            
          • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
            
          • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
            
            
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            • Ability to deal with ambiguity, creative and pragmatic approach to problem solving
              
            • Travel will be required between 15% and 25% of the time.
              
            • Auditor certifications a plus.
              
            • Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus. -
              
            • Collaborative, team-oriented mindset with strong verbal and written communication skills. -
              
              
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              • Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills. -
                
              • Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus. -
                
              • Collaborative, team-oriented mindset with strong verbal and written communication skills. -
                
              • Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
                
                Industry: -
                
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                • Biotechnology
                  
                  Employment Type:
                  
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                  • Full-time
                    
                    Equal Employment Opportunity:At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Keywords: Fusion Health, Redwood City , Manager, Quality Assurance, Executive , Redwood City, California