Job Description

Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Durham Posted Date: May 13 2025 Quality Business Partner, Director Are you interested in a highly visible, strategic role that allows you to deliver key insights in support of the GSK R&D Quality organisation? If so, this Quality Business Partner, Director role may be an exciting opportunity to explore. Job Purpose: The Quality Business Partner (QBP) is the quality advocate for their given area of responsibility. This role 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. You will support 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. Why you? Basic Qualifications: Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience. 10+ years of experience in drug development, regulatory compliance or quality management. Experience in matrix management and leadership to cross-functional teams. Experience in clinical, medical, pharmacovigilance or regulatory quality. Expert knowledge and experience of GCP, GLP, GVP and regulatory requirements. Preferred Qualifications: 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.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #J-18808-Ljbffr GlaxoSmithKline

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