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Quality Assurance Specialist

2 months ago

Stevenage, Hertfordshire, United Kingdom GSK Full time
Job Purpose

The role of Quality Assurance Specialist is to serve as the quality advocate for assigned areas of responsibility, providing strategic, expert advice and consultation on R&D quality with impact across the Good Practices. The specialist will educate assigned groups on Quality by Design, GxP risk minimization and mitigation, and help the business and GSK's Third Party partners understand potential impact of Quality risks and alternatives to best address the risk.

Key Responsibilities
  • Collaborate with business and/or Third Party teams to provide expert quality information, manage identified issues, and support continuous improvement particularly in scope of Health Care Technologies, IVDR, and clinical lab regulations.
  • Support evaluation of R&D to emerging Health Care Technologies and IVD regulations in our portfolio.
  • Support issue identification, reporting, root cause analysis, and CAPA development.
  • Provide matrix management and leadership to cross-functional teams.
  • Foster a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties.
  • Responsible for quality consultation for the assigned function, program, and/or Third Party.
  • Define, implement, and monitor the quality narrative/quality brief and report any critical risk.
  • Define the activities that need to be conducted to deliver the quality strategy for the assigned function, program, and/or Third Party.
  • Support due diligence and Merger & Acquisition activities.
  • Ensure rapid communication of quality issues and risks, including potential misconduct, to appropriate leaders and colleagues.
  • Support the investigations of potential serious breaches and critical issues.
  • Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.
  • Share key learnings to drive simplification and replicate best practices to drive quality into the business.
Minimum Requirements
  • Bachelor's Degree in a Scientific Discipline.
  • Experience in invitro device regulations.
  • Experience in healthcare technologies and devices from a quality and regulatory perspective.
Preferred Qualifications
  • Minimum 8 years in drug development, regulatory compliance, or quality management.
  • Minimum 3 years in clinical, medical, pharmacovigilance, or regulatory quality.
  • Demonstrated knowledge of GLP, GCP, GVP, and regulatory requirements.