Director, Quality Assurance Specialist
3 weeks ago
About the Role:
We are seeking a highly experienced Director, Quality Business Partner to join our team at GSK. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities:
* Serve as the Quality Business Partner for assigned GSK R&D functions, programs, and/or Third Parties
* Work closely with business to provide expert quality information, manage identified issues, and support continuous improvement
* Provide matrix management and leadership to cross-functional teams
* Collaborate 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
* Lead inspection readiness activities and support regulatory inspections
* Support issues identification, reporting, root cause analysis, and CAPA development
* Evaluate and/or review standard operating procedures and other activities in support of an integrated, cross-functional Quality Management System
* Influence senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties
Requirements:
* Degree qualified in a scientific or engineering discipline or able to demonstrate equivalent level of knowledge
* Experience in drug development, regulatory compliance, or quality management
* Experience in clinical, medical, pharmacovigilance, or regulatory quality
* Expert knowledge of GLP, GCP, GVP, and regulatory requirements
* Proven experience interfacing and influencing senior Global Leadership team stakeholders
* Strong leadership skills
* Ability to lead cross-functional project and/or matrix teams to an aligned strategy
About GSK:
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).
Why Work at GSK?
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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