Quality Business Partner, Third Party (R&D Quality and Risk Management) at GSK

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

14 Feb, 26

Salary

272250.0

Posted On

16 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Risk Management, Continuous Improvement, Analytical Skills, Communication Skills, Problem-Solving, Collaboration, Quality by Design, Clinical Quality, Third Party Management, GxP Regulations, Data Analytics, Inspection Readiness, CAPA Development, Due Diligence

Industry

Pharmaceutical Manufacturing

Description

Quality Business Partner, Third Party (R&D Quality and Risk Management) Job Purpose The Quality Business Partner (QBP) is the quality advocate for assigned areas 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 aligned groups on Quality by Design, regulatory compliance risk minimization and mitigation. The QBP will help the business and Third Parties understand potential impact of Quality risks and alternatives to best address them, while helping R&D implement strategies for quality and getting right first time as well as oversight according to the GSK ICF. Key Responsibilities: • Serves as the Quality Business Partner for assigned GSK R&D Third Party services. • Defines the activities that need to be conducted to deliver the quality strategy for the assigned Third Party services. • Implements and monitors the quality narrative/quality brief, reports any critical risk and the quality position/statement. • Works closely with business and/or Third Party teams to provide expert quality information and support continuous improvement. • Leads inspection readiness activities and supports regulatory inspections. • Evaluates, and/or reviews procedures and other activities in support of an integrated, cross functional QMS. • Fosters a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties. Facilitates effective communication and knowledge sharing across teams to promote a culture of quality. • Supports due diligence and Merger & Acquisition activities. • Works with R&D Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management and stakeholders. • Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues. • Supports issues identification, reporting, root cause analysis and CAPA development. • Supports the investigations of potential serious breaches and critical issues. • 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. • Participates in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT. • Shares key learnings to drive simplification and replicate best practices to drive quality into the business. Why You? Basic Qualifications Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience. Clinical Quality Assurance expertise. Experience in Third Party quality management and oversight. Experience in clinical, medical, pharmacovigilance or regulatory quality. Experience in GxP (GCP, GLP) regulatory requirements. Broad working knowledge and 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. Preferred Qualifications 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. Excellent problem-solving skills. Proven ability to collaborate across diverse teams. Quality Business Partner, Third Party (R&D Quality and Risk Management) Job Purpose The Quality Business Partner (QBP) is the quality advocate for assigned areas 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 aligned groups on Quality by Design, regulatory compliance risk minimization and mitigation. The QBP will help the business and Third Parties understand potential impact of Quality risks and alternatives to best address them, while helping R&D implement strategies for quality and getting right first time as well as oversight according to the GSK ICF. Key Responsibilities: • Serves as the Quality Business Partner for assigned GSK R&D Third Party services. • Defines the activities that need to be conducted to deliver the quality strategy for the assigned Third Party services. • Implements and monitors the quality narrative/quality brief, reports any critical risk and the quality position/statement. • Works closely with business and/or Third Party teams to provide expert quality information and support continuous improvement. • Leads inspection readiness activities and supports regulatory inspections. • Evaluates, and/or reviews procedures and other activities in support of an integrated, cross functional QMS. • Fosters a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties. Facilitates effective communication and knowledge sharing across teams to promote a culture of quality. • Supports due diligence and Merger & Acquisition activities. • Works with R&D Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management and stakeholders. • Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues. • Supports issues identification, reporting, root cause analysis and CAPA development. • Supports the investigations of potential serious breaches and critical issues. • 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. • Participates in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT. • Shares key learnings to drive simplification and replicate best practices to drive quality into the business. Why You? Basic Qualifications Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience. Clinical Quality Assurance expertise. Experience in Third Party quality management and oversight. Experience in clinical, medical, pharmacovigilance or regulatory quality. Experience in GxP (GCP, GLP) regulatory requirements. Broad working knowledge and 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. Preferred Qualifications 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. Excellent problem-solving skills. Proven ability to collaborate across diverse teams. LI-GSK* Hybrid* The US annual base salary for new hires in this position ranges from $163,350 to $272,250 The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive 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 https://openpaymentsdata.cms.gov/ We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.

Responsibilities

The Quality Business Partner (QBP) serves as the quality advocate for assigned GSK R&D Third Party services, providing strategic advice and consultation on R&D quality. The role involves implementing quality strategies, leading inspection readiness activities, and fostering a culture of quality across teams.