R&D Quality Business Partner

Job Purpose

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

• 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

Education Requirements

​Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.

Job Related Experience

Minimum:

• 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

Desired:

• 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.
• Fluent in both spoken and written Chinese and English.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. 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).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. 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. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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