Director, Healthcare Quality Specialist
4 weeks ago
The purpose of this role is to serve as the quality advocate for assigned areas of responsibility, providing strategic and expert advice on R&D quality and regulatory compliance. The role will educate assigned groups on Quality by Design, GxP risk minimization and mitigation, and support the business and GSK's Third Party partners in understanding potential quality risks and alternatives to address them.
Key Responsibilities- Collaborate with business and Third Party teams to provide expert quality information and manage identified issues.
- Support continuous improvement in the scope of Health Care Technologies, IVDR, and clinical lab regulations.
- Work closely with the Audit, Inspection, Risk, and Issue Management teams to ensure compliance with regulatory requirements.
- Evaluate R&D to emerging Health Care Technologies and IVD regulations in the portfolio.
- Support issue identification, reporting, root cause analysis, and CAPA development.
- Review and implement standard operating procedures to support 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.
- Bachelor's Degree in a Scientific Discipline.
- Experience in invitro device regulations.
- Experience in healthcare technologies and devices from a quality and regulatory perspective.
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
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