GlaxoSmithKline
Director, Risk Management (R&D Quality & Risk Mgmt/WWBD)
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Pennsylvania - Upper Providence, USA - Massachusetts - Cambridge, USA - Massachusetts - WalthamPosted Date:
Oct 31 2024Join us in driving innovation and speed in GSK R&D! As our
R&D Quality & Risk Management Director , you'll play a key role in proactively shaping product development through Quality by Design, partnering with teams to embed risk management and efficiency throughout the Product Lifecycle.In this role, you'll support seamless risk management execution across business lines, align with GSK's Internal Control Framework, and connect with Enterprise Risks. We're seeking a proactive professional experienced in assessing and mitigating risks to help build a strong, future-ready organization.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 programs,, pension plan membership, and shares and savings program.We embrace modern work practices; our Performance with Choice program offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.In this role you will:Support the assigned business line in implementing an effective Internal Control Framework (ICF), including fit-for-purpose Management Monitoring, informing both risk and audit universe
Collaborate with senior leaders to foster a culture of openness, transparency, and accountability, ensuring staff feel empowered to speak up.
Integrate risk management within R&D business planning and performance, proactively identifying and managing emerging risks to support business objectives.
Lead management review and reporting for R&D, using data-driven insights to promote continuous improvement and informed decision-making.
Contribute to the development and implementation of a streamlined Risk Management (RM) process, aligned with GSK's Quality Management System (QMS).
Partner with Quality and Compliance teams to link risk, issues, and corrective actions, guiding effective root cause analysis and CAPA execution.
Train and support business lines on risk management tools and methodology, offering guidance on policies, SOPs, and internal control frameworks.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:A degree (or equivalent) in a Scientific, Finance, Business or Economics Discipline
Experience (ideally in R&D) in Quality/audit/CAPAs, successfully executed in challenging circumstances, with multiple stakeholders and conflicting interests
Risk management experience in the pharmaceutical/vaccines industry, finance or business
Experience working on multiple projects led in a matrix environment
Experience (ideally in R&D) in quality- and risk management-related areas, including root cause analysis
Experience using risk management tools and methodology
Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:Proven record (ideally in R&D) of the ability to drive performance and influence stakeholders, including Sr Leaders; proven record of change management, streamlining and learning agility
Proven record of implementing the Internal Control Framework (ICF) and, in particular, Risk Management and Management Monitoring ICF elements, in a naive population, with successful outcome
Expertise in essential regulatory guidelines worldwide, as well as GSK company policies and procedures, e.g. detailed knowledge of GSK SOPs, ICH and FDA regulations as they impact all aspects of drug development. Alternatively hold a strong understanding of financial markets or business operation
Experience with problem solving, ability to work with self-discipline, operating under pressure, with changing priorities and difficult circumstances
Ability to drive pragmatic, data-driven decisions, focusing on high impact areas, with attention to detail, while fully taking into account the big picture and interconnections
#LI-GSKPlease 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 and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesGSK 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 GSK's Transparency Reporting For the Record site.
USA - Pennsylvania - Upper Providence, USA - Massachusetts - Cambridge, USA - Massachusetts - WalthamPosted Date:
Oct 31 2024Join us in driving innovation and speed in GSK R&D! As our
R&D Quality & Risk Management Director , you'll play a key role in proactively shaping product development through Quality by Design, partnering with teams to embed risk management and efficiency throughout the Product Lifecycle.In this role, you'll support seamless risk management execution across business lines, align with GSK's Internal Control Framework, and connect with Enterprise Risks. We're seeking a proactive professional experienced in assessing and mitigating risks to help build a strong, future-ready organization.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 programs,, pension plan membership, and shares and savings program.We embrace modern work practices; our Performance with Choice program offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.In this role you will:Support the assigned business line in implementing an effective Internal Control Framework (ICF), including fit-for-purpose Management Monitoring, informing both risk and audit universe
Collaborate with senior leaders to foster a culture of openness, transparency, and accountability, ensuring staff feel empowered to speak up.
Integrate risk management within R&D business planning and performance, proactively identifying and managing emerging risks to support business objectives.
Lead management review and reporting for R&D, using data-driven insights to promote continuous improvement and informed decision-making.
Contribute to the development and implementation of a streamlined Risk Management (RM) process, aligned with GSK's Quality Management System (QMS).
Partner with Quality and Compliance teams to link risk, issues, and corrective actions, guiding effective root cause analysis and CAPA execution.
Train and support business lines on risk management tools and methodology, offering guidance on policies, SOPs, and internal control frameworks.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:A degree (or equivalent) in a Scientific, Finance, Business or Economics Discipline
Experience (ideally in R&D) in Quality/audit/CAPAs, successfully executed in challenging circumstances, with multiple stakeholders and conflicting interests
Risk management experience in the pharmaceutical/vaccines industry, finance or business
Experience working on multiple projects led in a matrix environment
Experience (ideally in R&D) in quality- and risk management-related areas, including root cause analysis
Experience using risk management tools and methodology
Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:Proven record (ideally in R&D) of the ability to drive performance and influence stakeholders, including Sr Leaders; proven record of change management, streamlining and learning agility
Proven record of implementing the Internal Control Framework (ICF) and, in particular, Risk Management and Management Monitoring ICF elements, in a naive population, with successful outcome
Expertise in essential regulatory guidelines worldwide, as well as GSK company policies and procedures, e.g. detailed knowledge of GSK SOPs, ICH and FDA regulations as they impact all aspects of drug development. Alternatively hold a strong understanding of financial markets or business operation
Experience with problem solving, ability to work with self-discipline, operating under pressure, with changing priorities and difficult circumstances
Ability to drive pragmatic, data-driven decisions, focusing on high impact areas, with attention to detail, while fully taking into account the big picture and interconnections
#LI-GSKPlease 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 and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesGSK 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 GSK's Transparency Reporting For the Record site.