Director, PV QA DSI

Job Summary

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Description

Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US. Act as the PV QA REMS representative during US FDA inspections.

Responsibilities

• Lead the facilitation of a structured lessons learned framework in collaboration with stakeholders on audits, inspections, regulatory intelligence, and process improvement.
• Provide operational PV QA leadership and guidance to CSPV teams, ensuring compliance with regulatory requirements and the maintenance of robust quality management systems.
• Ensure adequate oversight of Quality Events and CAPA management, ensuring timely escalation and remediation.
• Proactively ensure sustained compliance across all PV-related functions, providing strategic PV QA oversight and advisory support to CSPV on procedural adherence and training needs.
• May be tasked as a PV QA reviewer to support/lead the review of the safety section of the dossier for regulatory submissions in collaboration with the Audit and Compliance team.
• Ensure that PV topics, risks, respective product profile targeting the population are addressed from a PV QA standpoint and represent PV QA at respective governance meetings as necessary.
• Support Head of PV QA Americas in ensuring robust management review of quality and compliance topics including the oversight of Key Quality Indicators (KQIs) and provide strategic PV QA recommendations to drive continuous improvement.
• Ensure proactive identification and mitigation of safety and compliance concerns in collaboration with business functions, and initiate and lead cross-functional quality and compliance improvement initiatives at local and global level.

Qualifications

• Bachelor's Degree Bachelor's degree in scientific, health care or related discipline; and/or background in Medical Health profession (RN, Medical Technologist, etc.). Master's preferred
• 10 or More Years 10 or more years of proven record in leading aspects of PV QA, involvement in regulated PV activities, in CSPV and PV QA (preferably) positions, or equivalent experience
• 10 or More Years 10 or more years working knowledge of drug development process to commercialization.
• 10 or More Years thorough and extensive knowledge of international GCP, GVP regulations and guidances including FDA, Health Canada, and ICH.
• 10 or More Years Excellent verbal and written communication skills/ computer skills
• Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation.
• Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas, and proven track record in leading teams and/or working groups.
• Experience in PV QA oversight of REMS programs is considered an advantage.

Additional Information

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.