Director, Medical Affairs QA

Daiichi Sankyo•Basking Ridge, NJ

32d•$180,880 - $271,320

About The Position

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.

Requirements

Must have a Bachelor's Degree in Life Sciences, Pharmacy or Medicines required
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.
Must have demonstrated knowledge and have a broad understanding of post marketing studies and post approval safety studies (PASS).
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.
Ability to travel up to 20% both domestic and international

Nice To Haves

Master's Degree preferred
PhD preferred
A background in biologics would be ideal.
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.

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.