Sr Manager Computer System Validation, Allendale

Must-Have:

• 
  
• 8 + years of experience working in an FDA-regulated, GMP-related environment. Pharma, Biotech, Medical Device industry.
  
• Implementation and change management of QMS (Quality Management System) and LIMS (Lab Information Management System).
  
• Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.
  
•  
  
• Responsibilities
  
• Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.
  
• Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.
  
• Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements
  

Qualifications

• 
  
• Bachelor’s Degree in a Scientific or Engineering discipline with eight (8) + years of computerized system experience with IT compliance/validation/qualification activities.
  
• Eight (8) + years of experience working in an FDA-regulated, GxP-related environment.
  
• Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
  
• Comprehensive knowledge in Software Validation and Data Integrity Principles.
  
• Demonstrated experience, results, and accomplishments in QMS (Quality Management Systems) and LIMS (Lab Information Management System) system implementations.
  
• Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
  
• Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
  
• Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
  
• Knowledge of Software Risk Management Principles and tools.
  
• Knowledge and proven ability working with Risk Management methodologies and tools.
  
• Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
  
• Experience with application system validation and infrastructure qualification.
  
• Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.
  
• Experience with writing and approving Standard Operating Procedures and Quality Standards.