Hiring: Manager, Quality Management Systems Company: Daiichi Sankyo Location: Basking Ridge, NJ Job Posted Time: 2026-09-16 19:01:03 Target Skills & Keywords : Regulatory Compliance About the job Required Skills: •Responsible for the managing and maintenance of the Quality Management System. This includes day-to-day support, continuous improvement, and ensuring the consistent implementation of global quality system policies. •Manages and adheres to Global Quality Management System (QMS) Identifies, triages, escalates and monitors quality issues and investigations across the organization. Elevates serious and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures. •Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management etc. Responsible for the timely completion global compliance, deviation, and CAPA commitments. •Partner cross-functionally with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Support the implementation of a single harmonized Quality approach across divisions. •Lead and oversee ensuring that the quality management system drives global regulatory compliance, is scalable and appropriate for the organization and product portfolio. Ensures consistency in implementation of global processes, CAPAs, and inspection responses. Manage key quality system projects driving alignment at all levels of the organization •Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partners with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements. •As needed, partner to support audits and inspections with the goal of compliance to regulations and global harmonization. Support identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations. •Lead and oversee supporting all aspects of the Quality Management System to support standards, procedures and compliance. Local and global responsibility for the day to day management of process effectiveness and where gaps are identified; proactively escalate to Senior Leadership, propose and implement solutions to ensure compliance. Qualifications: •Bachelor's Degree in Life Sciences, Engineering or Sciences required. A Master's Degree in Life Sciences, Engineering or Sciences preferred •Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management. Responsible for the timely completion global compliance, deviation, and CAPA commitments. preferred •Collaborating with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Supporting the implementation of a single harmonized Quality approach across divisions. preferred •Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partnering with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements. preferred •Partnering to support audits and inspections with the goal of compliance to regulations and global harmonization. Supporting identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations. preferred •Demonstrated capacity to effectively communicate and influence the outcomes of the decision-making process. Proven ability to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines preferred •Client focused and attention to detail. Demonstrated organizational and emotional intelligence and awareness. Strong leadership competencies with ability to work collaboratively with cross functional stakeholders to drive process improvements preferred •Strong critical thinking skills and serve as a positive QA ambassador during all daily activities and customer interactions. Demonstrated strong aptitude for facilitating group or project team activities and building team. •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. 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