Sr. Director, Quality (Medical Device/IVD)

Company: Talis Biomedical
Location: Redwood City
Posted on: September 17, 2023

Job Description:

Sr. Director, Quality (Medical Device/IVD)
SUMMARY OF POSITION
The primary function of the Senior Director, Quality is to provide leadership to assure the successful execution of Talis' Quality program and to be responsible for developing, implementing, and advising on strategies for development programs
POSITION RESPONSIBILITIES

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• Directs Talis'Quality function responsible for the Company's Quality System compliance with applicable regulatory agencies, Quality pre-market product and operations support, and strong functional leadership. Upon product launch, will be responsible for post-market Quality System compliance,post market surveillance including complaint monitoring, tracking and trending and resolution with Commercial.
  
• Sets the strategy to meet quality system, validation of design and design change. Champions design control rigor throughout the product lifecycle.
  
• LeadstheQuality Departmentincludingsettingprioritiesandstaffing. Hires, develops and assures the Quality Department staff reviews/approves quality documents that are in alignment with site Quality System and procedures.
  
• Implements, administers, and maintains the Company's document controlsystem and responsible for trainingofemployees,andwritingandupdatingQualityprocedures.
  
• Responsibleforriskmanagement (CAPA, Corrective Action Board, and non-conformity management) andchangecontrolactivities.
  
• Implements processes and procedures such as vendor audits, testing, etc., necessary tosupport productportfolios.
  
• Works with a broad range of internal functional groups including Operations, R&D, Project Management, and Product Management.
  
• Works closely with internal groups and outside agencies, as required, to assure compliance with regulations as part of the development and commercialization of the Company's intended clinical diagnosticproducts. Works with regulators related to product quality matters, as identified.
  
• Serves as a key focal point and participant in audits by external certifying bodies and/or regulatoryagencies. Directs and/or participates in vendor audits to assure conformity to stated specifications.
  
• WorkscloselywithProjectManagementtoensureQualitycompliancewithdesigncontroland product developmentprocesses. Provides oversight for product non-conformance situations and assure adequate investigation, correction action and close out actions implemented.
  
• Drivesbest practices and tools to improve execution and quality.Drives a culture of efficiency and accountability.
  
• Providesprojectanddepartmentupdatestothe executive team and advises senior management on action plans related to product quality andsafety.
  
  QUALIFICATIONS
  
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  • BS degree or equivalent, preferably in a Quality, Regulatory, Engineering or scientific/technical area. A minimum of 8-10 years progressive Quality, Regulatory Affairs, and technical experience.
    
  • IVD and molecular diagnostics experience required; Point of care (POC) regulated device experience.
    
  • A proven track record of having built and managed Quality and Regulatory teams.
    
  • ThoroughknowledgeofQSR/QSITandISO13485.
    
  • Product labeling expertise.
    
  • ProficiencyrelatedtotheincorporationofQualityelementsaspartofaphase gate process for developmentandlaunchofcommercialproducts.
    
  • Experience in CAPA and implementing quality and business processes improvement required.
    
  • Must be able to provide sound quality direction to set strategy and solve problems.
    
  • Proven structured thinking to accurately evaluate and assess processes and problems, identify and articulate possible solutions and drive to resolution.
    
  • Demonstratedleadershipto assureawell-developedQualitySystemandparticipation in audits byexternalcertificationorregulatoryagencies.
    
  • Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas.
    
  • Prior experience with IVD assay registration processes required.
    
    Communication & Interpersonal Skills:
    
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    • Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
      
    • Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
      
    • Strong negotiating skills and ability to think creatively and develop creative solutions.
      
    • Proven ability to build trust and respect within the organization.
      
    • Ability to prioritize and handle multiple projects.
      
    • Interacts with external business partners and Regulatory Agencies.
      
      This role will be based in either Chicago, IL or Redwood City, CA. Target compensation range for a Bay-area California hire is between $240-$275k, commensurate with overall experience. Meeting minimum requirements does not guarantee the highest end of the range.
      Some remote/hybrid work may be permitted.
      

Keywords: Talis Biomedical, Redwood City , Sr. Director, Quality (Medical Device/IVD), Healthcare , Redwood City, California