Sr. Director, Medical Affairs QA

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.