IT Quality- Consultant

Position Summary

This role offers a compelling opportunity to work with leading clients in the life sciences and healthcare space, supporting regulatory compliance, governance, and quality system validation initiatives. Youll be part of a dynamic team, driving innovation and ensuring adherence to global standards in regulated environments.

Key Responsibilities

• Regulatory Compliance:

  Identify and manage regulatory risks to support clients in compliance, governance, and control frameworks.

• Project Leadership:

  Lead and coordinate cross-functional teams for new product development, system validations, and quality assurance activities.

• Process Improvement:

  Assist clients in developing strategies for process improvements that align with the needs of the quality organization.

• Validation Expertise:

• Author validation strategies, protocols, and summary reports.
  
• Lead end-to-end computerized system validation (CSV) activities (experience is

  mandatory

  ).
• Plan, manage, and execute IQ, OQ, and PQ activities in accordance with cGMP.
  

• Cross-Functional Coordination:

  Collaborate with R&D, Engineering, Software Development, IT, Manufacturing, and QA teams for successful project execution and training.

• Documentation & Review:

• Review and approve validation lifecycle documentation.
  
• Identify and resolve validation deviations with appropriate CAPAs.
  
• Provide quality review of change requests related to processes, IT infrastructure, equipment, and systems.
  

• Project Governance:

  Manage project updates, escalation closures, and strategic decisions with senior management.

• Training & Knowledge Transfer:

  Initiate workshops and training sessions to build competence across teams.

About the Team

Regulatory & Operational Risk Life Sciences & Healthcare (R&OR LSHC)

Required Qualifications & Experience

• Bachelors degree (or equivalent)
  
• 2.5–5 years of experience in the

  pharmaceutical or medical device industry

• Strong understanding of

  quality systems

  and

  regulatory compliance

• Hands-on experience with:
  

• Computer system validation (CSV)

• Software development lifecycle

  methodologies (GAMP5, Agile, Waterfall)
• Demonstrated

  project management skills

  on medium to large-scale projects
• Proficiency in identifying risks, analyzing problems, and implementing effective solutions
  
• Strong communication and presentation abilities
  
• Team-oriented mindset with a collaborative approach
  

Preferred Qualifications

• Master’s degree in a relevant discipline
  
• In-depth knowledge of

  pharma and medical device quality systems

• Understanding of

  design controls

  ,

  manufacturing processes

  , and

  risk management principles