Strategic Quality Director, Business Partner

2 days ago


Stevenage, Hertfordshire, United Kingdom GSK Full time

GSK is a global biopharma company with a mission to unite science, technology and talent to get ahead of disease together. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas.

About this Role

This is an exciting position as the Associate Director, Quality Business Partner will be the quality advocate and change agent for their given area of responsibility. The role holder will provide strategic, expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility (in this case Third Parties).
The Associate Director, Quality Business Partner will drive quality into business by educating assigned groups on Quality by Design, regulatory compliance, risk minimization and mitigation.

Responsibilities
  • 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.
  • 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

A degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge.

Experience in drug development, regulatory compliance or quality management.

Expert knowledge of GLP, GCP, GVP and regulatory requirements.

Ability to lead cross-functional project and/or matrix teams to an aligned strategy.

What We Offer

We offer a competitive salary range of £80,000 - £120,000 per annum, depending on experience.

As an Equal Opportunity Employer, we are open to all talent.


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