QBP - Quality Business Partner

6 days ago

Stevenage, Hertfordshire, United Kingdom GSK Full time
Job Description

At GSK, we are seeking a highly skilled Quality Business Partner to join our team. As a key member of our organization, you will be responsible for providing expert quality advice and consultation to assigned groups, ensuring regulatory compliance and quality excellence across the board.

The ideal candidate will have a strong background in quality management, regulatory compliance, and risk management. They will be able to provide strategic guidance on quality by design, regulatory requirements, and risk minimization. Additionally, they will be able to educate assigned groups on quality principles and ensure that they are adhering to GSK's quality standards.

This is an exciting opportunity for a motivated and detail-oriented individual to join our team and contribute to the success of GSK. If you have a passion for quality and are looking for a challenging role, we encourage you to apply.

Key Responsibilities:

  • Provides matrix management and leadership to cross-functional teams.
  • Serves as the Quality Business Partner for assigned GSK R&D functions, programs, and/or Third Parties.
  • Works closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
  • Collaborates with the Audit, Inspection, Risk, and Issue Management team within R&D Quality and Risk Management on all internal quality audits, regulatory agency inspections, risk assessments, issue, and CAPA activities.
  • Leads inspection readiness activities and supports regulatory inspections.
  • Supports issues identification, reporting, root cause analysis, and CAPA development.
  • Evaluates and/or reviews standard operating procedures and other activities in support of an integrated, cross-functional QMS.
  • Influences senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties.
  • Responsible for quality consultation for the assigned function.
  • Defines, implements, and monitors the quality narrative/quality brief and reports any critical risk.
  • Works with R&D Data Analytics to define KPI, KQI, and metrics needs for R&D Quality and Risk Management and stakeholders.
  • Shares key learnings to drive simplification, continuous improvement, and replicate best practices to drive quality into the business.
  • Defines the activities that need to be conducted to deliver the quality strategy for the assigned function, program, and/or Third Party.
  • Supports due diligence and Merger & Acquisition activities.
  • Ensures rapid communication of quality issues and risks, including potential misconduct, to appropriate leaders and colleagues.
  • Supports the investigations of potential serious breaches and critical issues.
  • Leads special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.

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