Quality Business Partner - Development

Site Name: UK - London - New Oxford Street, Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Siena, UK - Hertfordshire - Stevenage
Posted Date: Nov 7 2024
Quality Business Partner - Development

Location: GSK HQ/Stevenage (UK), US

The purpose of the role is to be the quality advocate for their given area of responsibility. The Quality Business Partner will provide strategic, expert advice and consultation on R&D quality with impact across the regulatory and quality area of responsibility. 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.

Will help R&D design and implement strategies for quality and getting right first time as well as oversight according to the GSK ICF.

Key Responsibilities include, but are not limited to:

• 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.

Why you? Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience. 5 or more years of Pharma experience.
• Experience in drug development, regulatory compliance or quality management.
• Experience in clinical, medical, pharmacovigilance or regulatory quality.
• Expert knowledge of GCP, GVP regulatory requirements.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Broad working knowledge/expertise in principles and concepts of quality by design and risk management.
• Expert working knowledge in continuous improvement with a background in the appropriate tools.
• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
• Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
• Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments.
• Effective communication/negotiation skills and customer management skills.

Closing Date for Applications: 22nd November 2024 (COB)

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK .