Sr. Director, Medical Affairs QA
Location: Basking Ridge
Posted on: June 23, 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 The Senior Director, Head Medical affairs Quality Assurance
in Global RD/PV QA is accountable to drive the implementation of a
quality strategy and quality plan closely aligned with the Global
Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and
Specialty Business Unit (SBU) Medical Affairs business strategy .
This individual is also accountable to promote a quality culture
within across the product portfolio by providing governance
support, quality oversight of strategic initiatives in close
collaboration with cross functional leadership team (ie, OBU, SBU)
and study teams to uphold the ethical conduct of interventional,
non-interventional, investigator-initiated trials and managed
access programs to the highest quality standards. This position
reports to the Head, Global Development and Medical Affairs QA
RDPVQA, and oversees multiple levels of direct reports (Directors,
Associate Directors, Managers, contractors as applicable) across
the Global Quality teams located in EU, Americas (including Brazil)
and work in close collaboration with Japan. This individual is a
member of the Development and Medical Affairs QA leadership team
and maybe extended member of the global RD/PV QA leadership team.
The position will represent QA at Global Oncology Medical Affairs
LT, Specialty MA LT, Development (as applicable), GMP QA, and
engagement with external partners as deemed necessary. This
position is accountable to drive a proactive approach to quality
and instilling a shared passion for building a stronger Quality
organization with One Quality voice as the best trusted quality
partner with internal and external stakeholders. The incumbent must
aim to instill a consistent quality mindset and culture through
partnering with stakeholders to streamline the product lifecycle
process and develop risk mitigation strategies. Provide
comprehensive quality oversight and strategic quality
guidance/advice to the MA functions located in the Americas and EU
and collaborate with Research QA and Development QA to provide QA
advise wherever necessary for shared services between R&D and
Medical affairs, particularly in case when issues impact Medical
Affairs programs. Ensure requirements are in place for quality
oversight of marketed products in collaboration with Research QA,
PV QA, CSPV and other internal QA stakeholders such as GMP QA,
specifically for specialty pharmacy, REMS, co-partners and
affiliates. Liaise with Audit and Compliance team to ensure that
Global Medical Affairs audits are properly planned, communicated
and that audit targets for MA audits are in place. Review risk
assessment documents stemming from audit outcome to increase
compliance within MA function. Improve/strengthen QA engagement
with Global Oncology Medical Affairs, Specialty Medical affairs,
through lessons learned, process improvement and ongoing
collaborations. Provide end to end process consultation impacting
products from a quality perspective. Provide regular updates to
management on Mid Term strategy (MTS) for MA QA area and propose
improved objectives as necessary. Deliver risk mitigation
strategies and process improvements to stakeholders via the QMS
framework (i.e., Quality Management Review, Quality Review Board)
across the global medical affairs organization (Oncology and SM)
and relevant external stakeholders. The role will manage and or
support medical affairs Quality resources (US, Brazil, Japan/ APAC
and EU):in an efficient and effective manner including, but not
limited to oversight of defined work products, coaching and
mentoring of global team, performance management and
driving/contributing to organizational effectiveness/efficiencies.
RESPONSIBILITIES Customer Focus Provide Medical Affairs quality
oversight of the Oncology and Specialty Medicine portfolios, in
alignment with the business strategy Lead the DSG inspection
management activities by ensuring continued submission, compliance
and inspection preparedness for the respective MA inspections in
alignment with regulatory and company strategy. Act as management
representative for all key health authority inspections (US FDA, EU
EMA, MHRA etc.,). Develop and maintain an effective working
relationship with US FDA and other international bodies. Ensure
adequate CAPAs are defined, implemented, and closed through
providing guidance and facilitation of quality event resolution
Proactively ensure that all functions consistently operate in a
state of compliance. Facilitate the implementation of the quality
strategy in close alignment with the MA (Oncology and Specialty)
business strategy. Monitor and track implementation and break-down
of the Quality Manual into an annual Quality Plan together with the
supported MA teams, including the quality risk assessments and
inspection readiness components for the designated programs. Ensure
proactive representation of Quality professionals at strategic
non-project team and at MA strategic discussions. Lead the Quality
Reviews of respective product profile to ensure appropriate
management review of all quality and compliance related topics
including the review of Key Quality Indicators (KQIs). Collaborate
with Global QA teams in US, Japan, APAC, Europe and Brazil to
ensure relevant quality reports and or assigned by Head, Global
Development and Medical Affairs QA delivered in a timely manner.
Ensure that risks are duly identified, mitigated in collaboration
with the business functions. Identify appropriate continuous
improvement initiatives for quality and compliance related areas.
May Deputize for the Head, Global Development and Medical Affairs
QA at Leadership teams, as appropriate and as needed. Oversight:
Provide strategic direction pertinent to MA activities for internal
QA team (global/ local), but also to: Global Project Teams GOMA and
Specialty MA Management teams Data Management/ Biostats Clinical
Safety and Pharmacovigilance R&D Vendors/ CROs/ third parties
HEOR/ RWE Epidemiology Legal and compliance Marketing/ commercial
GMP QA/ Supply chain / Regulatory Affairs Leadership/ team
management: Create a high performing team environment and a
cohesive culture driven by values of integrity, respect, and a
speak up culture Lead and hold others accountable to performance,
talent, and development objectives Create an environment that
fosters diversity of thoughts, inclusivity and one that adheres to
the principals set forth in the organization (JOIN, GROW, THRIVE)
Create an environment that thrives on innovation, proactive quality
and is disciplined to efficiently execute against pre-defined
deliverables Drive employee engagement, mentoring, coaching and
performance management Exhibit servant leadership while driving
results. Collaborate with internal and external stakeholders
Interact with senior MA/functional leadership teams to ensure
Quality is consistently and proactively represented at program
level and support proactive quality risk management process.
Interact with the audit and compliance function for the development
of the UAP pertinent to MA area. Partners with the respective cross
functional groups, CROs, Affiliates in order to ensure high data
quality and proactive detection and resolution of issues. External
Engagement: Continuously review compliance metrics trends from
regulators/ industry experts and align develop the MA road map to
meet changing regulatory and business needs. Assure a closed loop
of MA risks identified through audits, inspections, internal
meetings, remediation and risk management in close collaboration
with the organization’s quality management system, to assure robust
knowledge transfer and continuous process improvement. Drive
effective relationship with alliance partners, legal and
compliance, collaborators, Marketing, R&D, vendors, and other
key company partners to ensure a culture of compliance at all
levels Influence change to drive continuous process improvement
with stakeholders Strategy: Contribute to shape the strategic
direction of the global Development and Medical QA function based
on the organization’s mid-term plan and beyond Ensure adequate MA
QA(Americas/Europe Brazil) resource are in place and contribute to
create a long term strategy for global MA QA across regions and
geographic areas. Contribute to create and maintain the strategic
road map, metrics, dashboard, and project management methodologies
to lead an efficient and effective organization Support the global
quality annual objectives, strategic initiatives to deliver against
the business plan. In close collaboration with GMP QA, CSPV, PV QA,
Research QA create a framework for cross collaboration related to
marketed / commercial products whereby MA is in scope for label
extension, safety only studies (PH IV studies) and/ or EAP
(Expanded access, lead and drive the strategic direction to ensure
adequate QMS is in place for continuous improvement. BASIC
QUALIFICATIONS Education Must have a BS Degree in a in scientific,
health care, or related discipline; and/or background in Medical
Health Profession (RN, Medical technologist, etc.) A Master's
Degree strongly preferred. Required Skills 10 or more years of
professional experience at senior management level leading quality
organization and demonstrated track record of successful results,
or equivalent experience from any of these industries:
Pharmaceuticals, biologics, Medical Device, Vaccines, Diagnostics,
Generics/ Consumer products Demonstrated expertise in managing many
aspects of quality in an international, global context in a
regulated health care environment Proven ability to work directly
with global Health Authorities (FDA, EMA, MHRA) and other
government and local agencies Expert knowledge required for the
end-to-end Drug development process in R&D space Strong
therapeutic experience specifically Oncology (biologics) is highly
preferred. Travel Requirement Must have the ability to travel both
domestic and globally up to 20% of the time. 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.
Keywords: , Danbury , Sr. Director, Medical Affairs QA, Science, Research & Development , Basking Ridge, Connecticut
