Director, Medical Affairs QA
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: October 30, 2025
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Job Description:
Join a Legacy of Innovation 125 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 125 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 18,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of
medicines for cardiovascular diseases, 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. 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 involves deputizing for the Sr.
Director, representing the Quality organization at senior levels.
The Director plays a pivotal role in regulatory inspections,
external audits, and high impact projects, fostering s culture of
excellence and compliance and working toward building a quality
mindset with Medical Affairs. Support the Sr. Director's Medical
Affairs Quality strategy by partnering with members and business
stakeholders for both Oncology and Specialty Affairs Medical
Affairs teams. Will provide strategic and proactive QA Leadership
and direction for respective interventional/non-interventional
programs such as post marketing studies or post approval
commitments, medical access programs. Partner with Medical Affairs
to facilitate the implementation of a risk-based quality management
process fully embedded through trial design, execution and
submission including all vendor managed activities with the goal of
achieving the highest data quality standards, full adherence to
patient's rights and well-being and in support of successful Health
Authority inspections and approvals - Proactively partner and lead
the strategic collaboration with other GxP Quality representatives,
and act as the Quality Assurance point person for all GxP matters
within the Medical Affairs team and with other related business
stakeholders. Drive necessary change and efficiency through
provision of effective feedback and recommendations. Identify and
raise areas of concern where quality gaps have been identified and
partner with Medical Affairs leaders to assign tasks to remove
those gaps. - Provide operational QA leadership and Quality
Oversight for the Quality Plan execution, Health Authority
Commitments, Critical Incidents including, respective escalation
and the CAPA Management Process for the respective business areas.
Responsibilities: Leadership and Project Management: Lead the
end-to-end quality execution across Medical Affairs programs,
ensuring compliance with GCP, GPV, GPEP, Data Protection, and other
local regulatory requirements throughout the planning and execution
of Interventional, Non-Interventional, Managed Access Programs, and
Investigator-Initiated Studies. Provide comprehensive quality
oversight for Medical Affairs activities, including interventional
studies, non-interventional studies, Compassionate Use or Managed
Access Programs. Collaborate with the Sr Director, Medical Affairs
QA to conduct quality reviews of product profiles, ensuring
thorough management review of all quality and compliance topics,
including Key Quality Indicators (KQIs). Identify and drive
initiatives for continuous quality improvement. Deputize for the
Sr. Director, Medical Affairs QA as needed. Cross-functional and
Global Team Participation: Drive quality excellence through
effective business partnerships with stakeholders across functions.
Provide leadership and guidance on assigned programs, collaborating
closely with the Head of Development and Medical Affairs QA to
implement the quality strategy and/or quality plan, fostering a
culture of quality within Medical Affairs. Lead strategic
initiatives in collaboration with Medical Affairs stakeholders to
uphold the ethical conduct of interventional, non-interventional,
investigator-initiated trials, and managed access programs to the
highest 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: Lead effective communication efforts within
the Medical Affairs team, ensuring collaboration with other GxP QA
functions (e.g., GMP/IMP QA, Audit and Compliance, QMS QA,
Development QA, and PVQA) to address GxP-related issues impacting
clinical/medical access programs. Drive necessary change and
efficiency through provision of effective feedback and
recommendations. Provide leadership and direction in the
development and execution of Corrective and Preventive Actions
(CAPAs), ensuring timely closure, effective checks, and the proper
escalation of critical issues. Partner with QMS QA to ensure
consistent implementation of applicable Quality Standards in
Medical Affairs and identify continuous improvement opportunities
in quality and compliance. Evaluate risks impacting GxP compliance
within Medical Affairs, driving ongoing improvements to meet
regulatory requirements and company policies and standards.
Interpret regulations, company standards, and guidelines for
personnel involved in assigned programs or continuous improvement
projects, championing and implementing study/program-specific
quality plans for proactive quality management. Collaborate with
the audit function, Data Management teams, MA stakeholders and CROs
to ensure high data quality, proactively identifying and resolving
issues throughout the clinical trial process. Customer Focus /
Stakeholder: Engagement Lead the implementation of the quality
strategy in alignment with the Medical Affairs business strategy.
Monitor and track the breakdown of the Quality Manual into an
annual Quality Plan, including quality risk assessments and
inspection readiness components for designated programs. Ensure
proactive representation of Quality professionals in strategic
project teams and GCP discussions, contributing to the broader
success of Medical Affairs goals. Promote open communication and
effective business partnering to support the cross-functional
implementation of Global RD/PV QA’s Strategy, Vision, and Mission.
Cultivate a culture focused on solution-oriented, evidence-based
decision-making and openness to innovative working methods and
technologies across cross-functional teams. Ensure consistent and
proactive representation of Quality at all stages of the program
management process. May Interact with management at all levels and
external audiences, leveraging a strong industry network.
Represents the organization in strategic discussions and quality
governance meetings. Quality Oversight: Ensure the timely
escalation of incidents/issues within Medical Affairs and QA,
providing oversight for deviation and incident investigations, and
ensuring that effective CAPAs are defined, implemented, and tracked
for closure. Oversee quality management within Medical Affairs
teams for third-party/vendor activities, ensuring that quality
standards are maintained in outsourced operations. Ensure CAPA
effectiveness checks are conducted and provide updates on quality
status to business functions in a timely manner through appropriate
forums, such as Quarterly Quality Reports (QQRs) and Quality Review
Boards (QRBs).Collaborate with business process owners to monitor
the effectiveness of clinical development processes through KQIs,
demonstrating process control and ensuring compliance levels are
met. Lead the process for reviewing and assessing KQIs regularly,
preparing management documentation for the QA Head, and ensuring
that any gaps or risks are addressed with continuous improvement
initiatives. Work directly with business process owners to
integrate quality into all stages of process development, ensuring
stakeholders are educated on common deviations. Ensure proper
planning and execution of and quality improvement initiatives to
reduce issues to build a stronger Quality driven organization.
Generate, analyze and report metrics to demonstrate key aspects of
compliance status, escalating issues in a timely manner for
earliest resolution, Regulatory Inspections: Facilitates regulatory
inspection preparation, management, and follow-up, ensuring
thorough management review of compliance topics. Acts as a key
representative during inspections and external audits. Ensure
ongoing submission and inspection readiness for the respective
Medical Affairs teams and related submissions, supporting the
preparation and management of regulatory inspections in
collaboration with business functions. Provide expert guidance to
enable successful inspections. Lead/Support local inspections by
providing adequate systems and process support, ensuring seamless
execution. Lead lessons learned efforts based on audit findings,
inspection results, regulatory intelligence, effectiveness checks,
and process improvements, ensuring CAPAs are coordinated and shared
to drive standardized responses and continuous learning across the
organization. Qualifications: Successful candidates will be able to
meet the qualifications below with or without a reasonable
accommodation. Education: Must have a Bachelor's Degree in Life
Sciences, Pharmacy or Medicines required Master's Degree preferred
PhD preferred Experience: Must have 10 or more years of
professional QA leadership experience within the pharmaceutical
industry with expertise in the involvement of regulated activities
for medical affairs, or clinical development. required Must possess
a solid understanding of global health authority regulatory
requirements particularly in the areas of Medical Affairs and
Clinical Development; Must have a strong understanding of
pharmaceutical drug development. A background in biologics would be
ideal. Must have demonstrated knowledge and have a broad
understanding of post marketing studies and post approval safety
studies (PASS). Demonstrated experience and proven track record of
successfully leading global projects with high impact with ability
to lead and project-manage cross-functionally and globally with
business stakeholders is highly-preferred Must have the proven
ability to influence others and to work collaboratively with team
leaders and business stakeholders cross-functionally and globally.
Must have demonstrated ability to handle advanced problem-solving
and decision-making skills, with expertise in conflict resolution
and negotiation. Must possess strong leadership, interpersonal,
communication, negotiation and problem-solving skills to be able to
effectively interact and present to management at all levels as
well as to external audiences and inspectors. Travel: Ability to
travel up to 20% both domestic and international 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 Download Our Benefits Summary PDF
Keywords: Daiichi Sankyo, Plainfield , Director, Medical Affairs QA, Science, Research & Development , Basking Ridge, New Jersey
