Job Description

Senior QA Manager, Computer System Validation (CSV QA) - Consultant 

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  Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic signatures and data integrity requirements (21 CFR Part 11, EU Annex 11).
  
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  Provide QA oversight for CSV activities for internal & external electronic systems, ensuring that CSV activities are conducted in compliance with global regulatory requirements (FDA, GAMP) and internal SDLC standards.
  
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  Implement best practices for data governance/integrity and ensure that all systems meet GxP compliance requirements.
  
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  Responsible for Quality oversight of Data Integrity and Computer System Validation activities.
  
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  Review and approve CSV deliverables, GxP change management requests, and quality records (e.g., Deviations, and CAPAs) to ensure adherence to Quality requirements.
  
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  Lead QA audits and/or assessment for supplier qualification or requalification of electronic system service providers.
  
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  Support process improvement efforts of computerized system policies, procedures and computerized system validation processes.
  
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  Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
  
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  Provide guidance to cross functional team, educate and train as necessary on risk-based approach for deployment of GxP systems.
  
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  Support Inspection Readiness initiatives, as well as providing support during partner audits and regulatory body inspections.
  

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  Extensive understanding of 21 CFR Part 11, Annex 11, and Data Integrity concepts and controls for computerized systems.
  
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  In-depth knowledge of GAMP 5, software development, lifecycle methodologies and current industry best practices.
  
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  Must have broad GxP electronic system experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization preferred.
  
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  Expertise in 21 CFR Part 11 and EU Annex 11 regulations, data integrity and GAMP5 concepts, applications, and best practices.
  

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  Hands-on experience in implementing and maintaining data integrity controls.
  
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  Experience supporting regulatory inspections and audits.
  
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  Experience working with all levels of management and consulting with key business stakeholders. An ability to influence greater outcomes.
  
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  Possesses strong written and verbal communication skills.
  

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