Daiichi Sankyo US
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Director, Medical Affairs QA
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Daiichi Sankyo US 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 125 years of scientific expertise and a presence in more than 20 countries, the Daiichi Sankyo group supports a robust pipeline of promising new medicines to help people, with a focus on oncology and other areas including rare diseases and immune disorders. Job Summary Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role deputizes for the Sr. Director, representing the Quality organization at senior levels and plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering a culture of excellence and compliance within Medical Affairs. Responsibilities Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for Oncology and Specialty Affairs Medical Affairs teams. Provide strategic QA leadership and direction for interventional/non-interventional programs such as post marketing studies or post approval commitments and medical access programs. Partner with Medical Affairs to implement a risk-based quality management process embedded through trial design, execution and submission, including all vendor managed activities, to achieve high data quality, protect patient rights and wellbeing, and support Health Authority inspections and approvals. Act as the Quality Assurance point person for all GxP matters within Medical Affairs and related stakeholders; drive change and efficiency with actionable feedback. Identify quality gaps and work with Medical Affairs leaders to assign tasks to close them. Provide operational QA leadership and oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents, escalation and CAPA management for the respective areas.
Leadership and Project Management
Lead end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and local regulatory requirements in Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies. Provide comprehensive quality oversight for Medical Affairs activities, including interventional and non-interventional studies, and Compassionate Use or Managed Access Programs. Collaborate with the Sr. Director, Medical Affairs QA to conduct quality reviews of product profiles, manage quality topics, and identify initiatives for continuous quality improvement. Depute for the Sr. Director, Medical Affairs QA as needed.
Cross-functional And Global Team Participation
Drive quality excellence through partnerships with stakeholders across functions. Provide leadership and guidance on assigned programs, collaborating with the Head of Development and Medical Affairs QA to implement the quality strategy and foster a culture of quality within Medical Affairs. Lead strategic initiatives with Medical Affairs stakeholders to uphold ethical conduct of interventional, non-interventional, investigator-initiated trials, and managed access programs to high quality standards. Act as the primary QA point of contact for all Medical Affairs programs, collaborating with GxP Quality representatives across the organization.
Quality Management And Continuous Improvement
Coordinate quality communications within the Medical Affairs team and with other GxP QA functions to address GxP issues impacting clinical/medical access programs; provide actionable feedback and recommendations. Lead CAPA development and closure, ensuring effective checks and timely escalation of critical issues. Partner with QMS QA to ensure consistent implementation of Quality Standards and identify continuous improvement opportunities in quality and compliance. Evaluate regulatory risks within Medical Affairs and drive ongoing improvements to meet regulatory requirements and company standards. Interpret regulations and guidelines for personnel involved in programs, championing study/program-specific quality plans for proactive management. Collaborate with audit, Data Management, MA stakeholders and CROs to ensure high data quality and resolve issues during the clinical trial process.
Customer Focus / Stakeholder
Lead implementation of the quality strategy aligned with Medical Affairs; monitor Quality Plan components and inspection readiness for designated programs. Represent Quality in strategic project teams and GCP discussions to support Medical Affairs goals. Promote open communication and effective business partnering to support cross-functional implementation of QA Strategy, Vision, and Mission. Cultivate a solution-oriented and evidence-based culture across cross-functional teams. Ensure proactive representation of Quality at all stages of program management. Interact with management and external audiences, representing the organization in quality governance meetings.
Quality Oversight
Escalate incidents timely within Medical Affairs and QA, oversee investigations and CAPA definitions, implementation and closure. Oversee quality management for third-party/vendor activities in Medical Affairs. Provide CAPA effectiveness checks and timely quality status updates through QQRs and QRBs; monitor KQIs and drive continuous improvement. Review and assess KQIs regularly; report to QA leadership and address gaps with improvement initiatives. Integrate quality into process development and educate stakeholders on deviations. Lead quality improvement initiatives to strengthen a Quality-driven organization. Generate and report metrics on compliance status and escalate issues for early resolution.
Regulatory Inspections
Prepare for regulatory inspections and manage follow-up; serve as a key representative during inspections and audits; ensure submission readiness and guidance for successful inspections. Lead local inspections with process support to ensure seamless execution. Lead lessons learned from audits, inspections, and regulatory intelligence; coordinate CAPAs and share learnings across the organization.
Qualifications
Education Bachelor's Degree in Life Sciences, Pharmacy or Medicines required Master's Degree preferred PhD preferred
Experience 10+ years of professional QA leadership experience in the pharmaceutical industry with expertise in Medical Affairs or Clinical Development; regulated activities experience required Strong understanding of global health authority regulatory requirements in Medical Affairs and Clinical Development; background in biologics is a plus Knowledge of post marketing studies and post-approval safety studies (PASS) Proven ability to lead global projects cross-functionally and cross-border Strong influencing, communication, negotiation, and problem-solving skills; ability to present to management and inspectors
Travel
Ability to travel up to 20% domestically and internationally
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range $180,880.00 - $271,320.00 Seniority level Not Applicable Employment type Full-time Job function Health Care Provider Industries Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing #J-18808-Ljbffr
Director, Medical Affairs QA
role at
Daiichi Sankyo US 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 125 years of scientific expertise and a presence in more than 20 countries, the Daiichi Sankyo group supports a robust pipeline of promising new medicines to help people, with a focus on oncology and other areas including rare diseases and immune disorders. Job Summary Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role deputizes for the Sr. Director, representing the Quality organization at senior levels and plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering a culture of excellence and compliance within Medical Affairs. Responsibilities Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for Oncology and Specialty Affairs Medical Affairs teams. Provide strategic QA leadership and direction for interventional/non-interventional programs such as post marketing studies or post approval commitments and medical access programs. Partner with Medical Affairs to implement a risk-based quality management process embedded through trial design, execution and submission, including all vendor managed activities, to achieve high data quality, protect patient rights and wellbeing, and support Health Authority inspections and approvals. Act as the Quality Assurance point person for all GxP matters within Medical Affairs and related stakeholders; drive change and efficiency with actionable feedback. Identify quality gaps and work with Medical Affairs leaders to assign tasks to close them. Provide operational QA leadership and oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents, escalation and CAPA management for the respective areas.
Leadership and Project Management
Lead end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and local regulatory requirements in Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies. Provide comprehensive quality oversight for Medical Affairs activities, including interventional and non-interventional studies, and Compassionate Use or Managed Access Programs. Collaborate with the Sr. Director, Medical Affairs QA to conduct quality reviews of product profiles, manage quality topics, and identify initiatives for continuous quality improvement. Depute for the Sr. Director, Medical Affairs QA as needed.
Cross-functional And Global Team Participation
Drive quality excellence through partnerships with stakeholders across functions. Provide leadership and guidance on assigned programs, collaborating with the Head of Development and Medical Affairs QA to implement the quality strategy and foster a culture of quality within Medical Affairs. Lead strategic initiatives with Medical Affairs stakeholders to uphold ethical conduct of interventional, non-interventional, investigator-initiated trials, and managed access programs to high quality standards. Act as the primary QA point of contact for all Medical Affairs programs, collaborating with GxP Quality representatives across the organization.
Quality Management And Continuous Improvement
Coordinate quality communications within the Medical Affairs team and with other GxP QA functions to address GxP issues impacting clinical/medical access programs; provide actionable feedback and recommendations. Lead CAPA development and closure, ensuring effective checks and timely escalation of critical issues. Partner with QMS QA to ensure consistent implementation of Quality Standards and identify continuous improvement opportunities in quality and compliance. Evaluate regulatory risks within Medical Affairs and drive ongoing improvements to meet regulatory requirements and company standards. Interpret regulations and guidelines for personnel involved in programs, championing study/program-specific quality plans for proactive management. Collaborate with audit, Data Management, MA stakeholders and CROs to ensure high data quality and resolve issues during the clinical trial process.
Customer Focus / Stakeholder
Lead implementation of the quality strategy aligned with Medical Affairs; monitor Quality Plan components and inspection readiness for designated programs. Represent Quality in strategic project teams and GCP discussions to support Medical Affairs goals. Promote open communication and effective business partnering to support cross-functional implementation of QA Strategy, Vision, and Mission. Cultivate a solution-oriented and evidence-based culture across cross-functional teams. Ensure proactive representation of Quality at all stages of program management. Interact with management and external audiences, representing the organization in quality governance meetings.
Quality Oversight
Escalate incidents timely within Medical Affairs and QA, oversee investigations and CAPA definitions, implementation and closure. Oversee quality management for third-party/vendor activities in Medical Affairs. Provide CAPA effectiveness checks and timely quality status updates through QQRs and QRBs; monitor KQIs and drive continuous improvement. Review and assess KQIs regularly; report to QA leadership and address gaps with improvement initiatives. Integrate quality into process development and educate stakeholders on deviations. Lead quality improvement initiatives to strengthen a Quality-driven organization. Generate and report metrics on compliance status and escalate issues for early resolution.
Regulatory Inspections
Prepare for regulatory inspections and manage follow-up; serve as a key representative during inspections and audits; ensure submission readiness and guidance for successful inspections. Lead local inspections with process support to ensure seamless execution. Lead lessons learned from audits, inspections, and regulatory intelligence; coordinate CAPAs and share learnings across the organization.
Qualifications
Education Bachelor's Degree in Life Sciences, Pharmacy or Medicines required Master's Degree preferred PhD preferred
Experience 10+ years of professional QA leadership experience in the pharmaceutical industry with expertise in Medical Affairs or Clinical Development; regulated activities experience required Strong understanding of global health authority regulatory requirements in Medical Affairs and Clinical Development; background in biologics is a plus Knowledge of post marketing studies and post-approval safety studies (PASS) Proven ability to lead global projects cross-functionally and cross-border Strong influencing, communication, negotiation, and problem-solving skills; ability to present to management and inspectors
Travel
Ability to travel up to 20% domestically and internationally
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range $180,880.00 - $271,320.00 Seniority level Not Applicable Employment type Full-time Job function Health Care Provider Industries Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing #J-18808-Ljbffr