Job Duties

• Quality Coaching ?? Coach employees on regulatory compliance, quality practices and the QMS (In-person, by video conference, Web Ex, and or teleconference)
  
• Quality Reviews ?? Perform reviews of project deliver ables, training materials, sales proposals, etc.
  
• Auditing (Internal, External, Facilitation) ?? Prepare documentation for auditor examination, coordinating resources, respond to audit findings (if any), and manage remediation efforts (if any) to closure.
  
• Development/Refinement of QMS documents ? Participate in writing Standard Operating Procedures (SOPâ??s), working practices, business process improvement, etc.
  
• Provide QMS training
  

Education and Other Qualifications

• Bachelor??s Degree or higher
  
• Previous Quality Assurance and Computer System Validation experience, ideally with Drug Safety Systems.
  
• Technical Writing (Strong Microsoft Office skills)
  
• JIRA experience is very helpful
  
• Ability to be client-facing and effectively lead discussions and presentations
  
• GAMP5 familiarity, including the V-Model, System Classification, and Criticality Assessments
  
• Has previously served in a Validation Leadership role on at least 3 Enterprise GXP projects, or 6 smaller divisional GXP roll-outs or upgrade
  
• Familiarity in a PV, GCP\\Safety environment is highly desirable
  
• Familiarity with 21CFR Part11 and EU Annex 11 Assessments
  
• Familiarity with Defect/Deviation Management and/or CAPA Management
  

Nice to Haves

• Agile SDLC experience
  
• ISO27001 or SSAE16 SOC1/2 Accreditation
  
• Has supported or defended validation during internal and external audits
  
• Ability to read SQL code
  
• MHRA Data Integrity Assessments
  
• Privacy Framework Compliance (Privacy Shield, ASIP Sante, EU Model Contracts, Safe Harbor)