Hiring: Director, PV QA DSI Company: Daiichi Sankyo Location: Basking Ridge, NJ Job Posted Time: 2026-09-10 14:01:09 Target Skills & Keywords : GCP, Project Management, Quality Assurance About the job Required Skills: •Provide PV QA oversight of the company products, in alignment with the business strategy. •Provide strategic direction pertinent to REMS activities for internal QA team (global/ local), and not limited to: Global Project teams, Safety Management, Clinical Safety and Pharmacovigilance, Companion Diagnostics/ Device, Pharmacies, Vendors/ CRO and Commercial Qualifications: •Bachelor's Degree Bachelor's degree in scientific, health care or related discipline; and/or background in Medical Health profession. Master's preferred required Master's Degree 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 required. required •10 or More Years 10 or more years working knowledge of drug development process to commercialization. preferred •10 or More Years thorough and extensive knowledge of international GCP, GVP regulations and guidances including FDA, Health Canada, and ICH. preferred •10 or More Years Excellent verbal and written communication skills/ computer skills preferred •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. •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!