Regulatory IT QA Lead Consultant


Posted: 12/01/2022

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**This is a Contract Role***

SQA Group is a tech and advisory services firm helping companies maximize two business differentiators — quality and data. We help both tech and business leaders see around corners, stand-up new capabilities, and elevate software quality and data as competitive advantages that help drive towards next.

SQA is working with a leading pharmaceutical company that needs additional bandwidth in their IT QA team.
We are looking for an IT QA resource to support their GMP, GDP and GVP systems. This position will support the Quality Information Systems Management (QISM) group working closely with the operational functions and other QA groups to provide oversight of GxP computerized system implementation, maintenance, and retirement.

This role will review and approve computerized system lifecycle documentation and provide GAMP, Part 11/ Annex 11, and data integrity expertise to key stakeholders.

What You Bring

  • Strong knowledge in Pharma and Biotech manufacturing systems; Typical applications include GVP (Argus safety database, Veeva Safety docs), GDP (product serialization systems), enterprise manufacturing systems such as POMS MES, and Oracle EBS OPM
  • Performing Quality Assurance functions related to Computerized Systems
  • 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

What You’ll Do

  • Develops an understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP 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 existing computerized systems used in the GCP / GMP areas
  • Consults with 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 the manager/leadership team
  • Provide support to regulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities
  • Lead and support projects with minimal guidance and support

Thank you for your interest in pursuing a career at SQA Group! This role is fully remote. SQA Group is an equal opportunity employer and supports workforce diversity. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities above are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.