GlaxoSmithKline
Director, Quality Business Partner
GlaxoSmithKline, Cambridge, Massachusetts, us, 02140
Site Name:
UK - Hertfordshire - Stevenage, Belgium-Wavre, Durham Blackwell Street, UK – London – New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date:
Oct 31 2024Director, Quality Business Partner – Third PartyThis role will preferably be based at GSK HQ or Stevenage, UK but can also be based at other strategic locations on a case-by-case basis.There are two Director, QBP positions that we are recruiting for.This is a truly exciting position as the Quality Business Partner will be the quality advocate and change agent for their given area of responsibility. The role holder will provide strategic, expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility (in this case Third Parties). The role will drive quality into business by educating assigned 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 the risk.They will help R&D to design and implement strategies for quality and getting right first time as well as oversight according to the GSK Internal Control Framework.In this role you will:Serve as the Quality Business Partner for assigned GSK R&D functions, programs and/or Third Parties.Work closely with business to provide expert quality information, manage identified issues and support continuous improvement.Provide matrix management and leadership to cross-functional teams.Collaborate 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.Lead inspection readiness activities and support regulatory inspections.Support issues identification, reporting, root cause analysis and CAPA development.Evaluate, and/or review standard operating procedures and other activities in support of an integrated, cross functional Quality Management System.Influence senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties.CLOSING DATE for applications: 21st November 2024Required qualifications and skills:Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge.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.Proven experience interfacing and influencing senior Global Leadership team stakeholders.Strong leadership skills.Ability to lead cross-functional project and/or matrix teams to an aligned strategy.Preferred qualifications and skills:BA/BS or Masters Degree.Broad working knowledge/expertise in principles and concepts of quality by design, quality briefs 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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only).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.
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UK - Hertfordshire - Stevenage, Belgium-Wavre, Durham Blackwell Street, UK – London – New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date:
Oct 31 2024Director, Quality Business Partner – Third PartyThis role will preferably be based at GSK HQ or Stevenage, UK but can also be based at other strategic locations on a case-by-case basis.There are two Director, QBP positions that we are recruiting for.This is a truly exciting position as the Quality Business Partner will be the quality advocate and change agent for their given area of responsibility. The role holder will provide strategic, expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility (in this case Third Parties). The role will drive quality into business by educating assigned 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 the risk.They will help R&D to design and implement strategies for quality and getting right first time as well as oversight according to the GSK Internal Control Framework.In this role you will:Serve as the Quality Business Partner for assigned GSK R&D functions, programs and/or Third Parties.Work closely with business to provide expert quality information, manage identified issues and support continuous improvement.Provide matrix management and leadership to cross-functional teams.Collaborate 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.Lead inspection readiness activities and support regulatory inspections.Support issues identification, reporting, root cause analysis and CAPA development.Evaluate, and/or review standard operating procedures and other activities in support of an integrated, cross functional Quality Management System.Influence senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties.CLOSING DATE for applications: 21st November 2024Required qualifications and skills:Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge.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.Proven experience interfacing and influencing senior Global Leadership team stakeholders.Strong leadership skills.Ability to lead cross-functional project and/or matrix teams to an aligned strategy.Preferred qualifications and skills:BA/BS or Masters Degree.Broad working knowledge/expertise in principles and concepts of quality by design, quality briefs 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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only).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.
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