Manager, Medical Affairs Quality, RD PV QA

Job Title: Manager, Medical Affairs Quality, RD PV QA Job Summary The Manager, Medical Affairs Quality will provide operational leadership and direction for assigned programs and, in close collaboration with the Sr. Director, Medical Affairs QA, ensure implementation of the quality strategy and/or quality plan to promote a quality culture within Medical Affairs. The Manager, Medical Affairs Quality supports quality oversight of strategic initiatives in partnership with Medical Affairs stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, real world evidence and managed access programs to the highest quality standards. The role participates in the review of quality and compliance topics, including key quality indicators at Quality Governance Meetings, and works closely with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement. The Manager, Medical Affairs Quality, promotes end-to-end, comprehensive quality execution across programs, ensuring GCP, GVP, Data Protection, and other local requirements are considered in planning and conduct. Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues. The Manager facilitates regulatory inspection preparation, management, and follow-up in collaboration with business functions, supports local inspections with adequate systems and process support, and partners with QMS QA to ensure aligned implementation of applicable Quality Standards. Additionally, the Manager identifies opportunities for continuous improvement in quality and compliance through lessons learned from audits, inspections, incidents, regulatory intelligence, and effectiveness checks, and provides interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects. The Manager champions and helps implement study/program-specific quality plans to ensure proactive management of quality and fosters strong relationships with stakeholders to drive a culture of compliance and operational excellence. Responsibilities Leadership and Project Management: Promote end-to-end, comprehensive quality execution across assigned programs, ensuring GCP, GPV, Data Protection, and local requirements are integrated into the planning and conduct of Interventional, Non-interventional, Compassionate Use Managed Access Programs, and Investigator-Initiated Studies. Provide operational quality oversight for Medical Affairs activities, including timely escalation of incidents/issues, monitoring deviations/incidents, supporting investigations, and coordinating with third-party vendors. Serve as a key liaison to support audits and inspections as applicable. Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement. Provide quality oversight and uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards in close collaboration with Medical Affairs stakeholders. Collaborate with GxP Quality representatives and act as QA point person for all Medical Affairs programs. Quality Management and Continuous Improvement: Provide guidance during the development and execution of CAPAs, including tracking of timely closure, effectiveness checks, and escalation of critical issues. Partner with QMS QA to ensure aligned implementation of applicable Quality Standards in Medical Affairs and identify appropriate continuous improvement initiatives. Provide interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects. Champion and help implement study/program-specific quality plans to ensure proactive management of quality. Customer Focused / Stakeholder Engagement: Work in close collaboration with Medical Affairs stakeholders to uphold ethical conduct and enhance compliance and quality standards across programs; share lessons learned and contribute to a quality mindset within Medical Affairs. Collaborates with QA line functions and Medical Affairs stakeholders to improve compliance and quality standards. Acts as a QA point person for assigned programs. Regulatory Inspections: Facilitate regulatory inspection preparation, management, and follow-up in collaboration with business functions; support local inspections with adequate systems and process support. Contribute to lessons-learned information flow based on audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics. Qualifications Education Qualifications: Bachelor’s Degree in Life Sciences, Pharmacy or Medicines required; Master’s Degree or other advanced degree preferred. Experience Qualifications: 4 or more years of experience in the pharmaceutical industry, preferably in clinical development or Medical Affairs, with exposure to regulated GCP environments required. Profound knowledge of global drug development processes and regulations, including ICH‑GCP, FDA/EU requirements, pharmacovigilance, and current industry practices preferred. Ability to interpret and apply complex regulations, standards, and policies to operational activities preferred. Experience supporting regulatory inspections and audits. Demonstrated initiative in identifying and implementing process improvements. Demonstrated experience supporting high‑impact projects in a matrixed, global environment. Strong interpersonal skills with the ability to build collaborative relationships across functions and geographies. Excellent project management skills, including the ability to manage multiple priorities and deliver results in a dynamic business environment. Effective verbal and written communication skills, with proficiency in presenting complex information to diverse audiences. Strong analytical, problem‑solving, and decision‑making abilities. Skilled at conflict resolution and negotiation, with a focus on achieving alignment and consensus. Ability to work independently and as part of cross-functional teams, influencing and driving initiatives within assigned scope. Flexibility and adaptability to changing business needs and priorities. Organizational awareness, including understanding of interdepartmental relationships and business priorities. 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: USD$116,400.00 - USD$174,600.00 #J-18808-Ljbffr Initial Therapeutics, Inc.