Daiichi Sankyo
Executive Director, Research QA
Daiichi Sankyo, Trenton, New Jersey, United States,
Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SUMMARYDevelop the strategic direction for Global Research QA including activities under GLP, GCLP, Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately.Support Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally.Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed.Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices.Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts.ResponsibilitiesLeads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure/support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.Manage and/or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND).Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc.Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight.Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/research unit for global activities and regulators.Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation.QUALIFICATIONSSuccessful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Must have a Bachelor's Degree in Life Sciences, Pharmacy or MedicinesPhD or other post graduate degree strongly preferredExperience QualificationsMust have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions.Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines.Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required.Must have strong communications skills, written and oral.TravelMust have the ability to travel up to 20%. Domestic and International travel.
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Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SUMMARYDevelop the strategic direction for Global Research QA including activities under GLP, GCLP, Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately.Support Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally.Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed.Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices.Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts.ResponsibilitiesLeads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure/support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.Manage and/or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND).Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc.Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight.Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/research unit for global activities and regulators.Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation.QUALIFICATIONSSuccessful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Must have a Bachelor's Degree in Life Sciences, Pharmacy or MedicinesPhD or other post graduate degree strongly preferredExperience QualificationsMust have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions.Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines.Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required.Must have strong communications skills, written and oral.TravelMust have the ability to travel up to 20%. Domestic and International travel.
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