Medical Quality Specialist

4 weeks ago

London, Greater London, United Kingdom GlaxoSmithKline Full time

About this role

We are seeking a highly skilled Medical Quality Specialist to join our R&D team at GlaxoSmithKline. This is an exciting opportunity for an experienced professional in invitro device regulations and healthcare technologies to take their career to the next level.

Job summary

The Medical Quality Specialist will be responsible for providing strategic, expert advice and consultation on R&D quality with impact across the Good Practices. This includes educating assigned groups on Quality by Design, GxP risk minimization and mitigation, and helping the business and GSK's Third Party partners understand potential impact of Quality risks and alternatives to best address the risk.

Key responsibilities

  • Serve as the quality business partner for assigned GSK R&D functions, programs and/or Third Parties supporting Health Care technologies, Invitro devices (IVDs) and lab methods.
  • Work closely 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.
  • Collaborate with the Audit, Inspection, Risk and Issue Management teams within R&D Quality and Risk Management function on all internal quality audits, regulatory agency inspections, risk assessments, issue and CAPA activities.
  • 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.
  • Evaluate, and/or review standard operating procedures and perform other activities in support of an integrated, cross functional QMS.
  • 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.
  • Be 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.

About you

To succeed in this role, you will need a Bachelor's Degree in a Scientific Discipline and experience in invitro device regulations. You should also have knowledge of GLP, GCP, GVP and regulatory requirements. Minimum 8 years in drug development, regulatory compliance or quality management would be beneficial, as well as minimum 3 years in clinical, medical, pharmacovigilance or regulatory quality.

Salary and benefits

The salary for this role is approximately £60,000-£80,000 per annum, depending on your level of experience. In addition to a competitive salary, we offer a comprehensive benefits package, including a generous pension scheme, life insurance, and access to a range of employee discounts.

Why join us?

At GlaxoSmithKline, we are committed to creating a workplace that is inclusive, diverse and supportive. We believe that everyone has the right to feel valued and respected, regardless of their background, ethnicity, age, disability, sexual orientation or gender identity. If you share our values and want to make a difference, we encourage you to apply for this exciting opportunity.

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