Director, Quality Business Partner

GSK

1d•Hybrid

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. As Director QBP, you will act as the trusted quality partner for assigned functions and third parties. You will give practical, clear quality advice and help teams reduce risk while improving how work gets done. You will shape quality strategies that enable reliable delivery, support quality investigations, and participate in inspection readiness activities. We value curious, collaborative people who coach others, simplify processes, and build strong relationships across teams. This role offers growth, real impact on how we work, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together. The role will educate assigned groups on Quality by Design, regulatory compliance, risk minimization and mitigation. The QBP will help the business and TP understand potential impact of Quality risks and alternatives to best address the risk.

Requirements

Bachelor’s degree in life sciences, pharmacy, engineering, or related discipline, or equivalent experience.
Minimum 5 years’ experience in quality, compliance, or regulatory roles within the life sciences industry.
Experience in drug development, regulatory compliance or quality management.
Experience in matrix management and leadership to cross-functional teams.
Expert knowledge and experience of GCP, GLP, GVP and regulatory requirements.
Ability to lead investigations, perform root cause analysis and deliver effective CAPAs.
Stakeholder skills with experience influencing cross-functional teams and senior leaders.

Nice To Haves

Advanced degree in a scientific or quality-related field or formal quality/compliance certification.
Experience implementing quality by design, risk-based quality management, and continuous improvement tools.
Familiarity with regulated systems and quality metrics, including KPI/KQI development and reporting.
Experience working with regulated R&D or manufacturing environments, including inspection readiness at pace.
Comfort working in a matrix organization and leading through influence across multiple locations.
Digital awareness, including use of analytics or quality management systems to drive improvement.

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 learning’s 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.