Senior Quality Validation Lead (Boston)

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• Understands regulations pertaining to the implementation and use of computerized systems in all GxP areas.
• Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
• Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas.
• Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity.
• Identifies and escalates areas of risk or non-compliance to manager / leadership team.
• Participates in performing Periodic Review activities of Computerized Systems.
• Provide support to regulatory inspection preparedness activities as needed.
• Experience performing Infrastructure Qualification activities.
  

• Understands regulations pertaining to the implementation and use of computerized systems in all GxP areas.
• Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
• Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas.
• Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity.
• Identifies and escalates areas of risk or non-compliance to manager / leadership team.
• Participates in performing Periodic Review activities of Computerized Systems.
• Provide support to regulatory inspection preparedness activities as needed.
• Experience performing Infrastructure Qualification activities.
  

• Bachelor's degree and relevant GxP work experience.
• Proficiency in using Microsoft Office applications.
• 8-10 experience performing validation activities.
• Proficiency with regulations related to FDA / MHRA regulations.
• Use of computerized quality management systems.
• Experience with validation of Enterprise / Lab Computerized Systems.
• Quality metrics, dashboards, analysis and improvement programs.
• Knowledge of GAMP and Agile validation lifecycle and methodologies.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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