Head of Quality Assurance, Drug Product, GMP QA

Job Requisition ID: 1674 Posting Start Date: 6/22/26 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 Summary The Head of Quality Assurance, Drug Product is accountable for the quality oversight of internal sites and Contract Development and Manufacturing Organizations (CDMO). The role leads the site's independent Quality Assurance organization, accountable for an effective, risk‑based quality system. It is responsible for inspection performance/readiness activities, data integrity, and ensuring final batch disposition and lot release activities to support patient needs and demand. Partners with Regulatory Affairs, Supply Chain, Tech Unit and global Quality leaders to assure supply and compliance while promoting a culture of continuous improvement. As a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Responsibilities Lead a team of 5–7 MSMQs responsible for the independent QA function, with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production per Daiichi Sankyo's GMP Quality Manuals. Resolve quality performance issues escalated from MSMQs, collaborating with Tech Unit senior leaders and other internal peer groups, and escalating to GMQ Head when necessary. Ensure the local QMS remains fully compliant with the global Quality Manual by managing key pillars such as CAPA, change control, and data integrity, using a risk‑based approach for periodic reviews. Provide hands‑on leadership to ensure the seamless execution of QA functions, including complaint management, root‑cause investigations, and reporting of critical GMP issues to senior management. Direct the batch release process by overseeing complex jurisdiction controls and cross‑functional data integration, ensuring all disposition decisions align with Daiichi Sankyo's Quality digital roadmap and analytics strategy. Drive continuous improvement across the site, spearheading initiatives to reduce deviations, shorten manufacturing cycle times, and strengthen the CAPA system. Support the enhancement of a robust Integrated Risk Management framework, identifying potential risks throughout the product lifecycle and implementing proactive mitigation strategies. Represent QA in internal and external leadership forums and strategic initiatives. Drive institutional adherence to international regulatory frameworks, overseeing the implementation of quality policies that satisfy cGMP, FDA, EMA, ANVISA, PMDA, and ICH guidelines. Represent the company to health authorities, expertly navigating audit dynamics and ensuring the compliance posture is defended. Collaborate with product quality counterparts to ensure an accurate clinical trial document review process. Propose resource allocation and MSMQ deployment to the Global Manufacturing Quality Head. Partner with HR to oversee talent selection, development, and evaluation of direct reports. Foster a culture of accountability, transparency, and continuous improvement. Qualifications Education Qualifications Bachelor's Degree in a science‑related discipline required. An Advanced Degree strongly preferred. Experience Qualifications 10+ years of experience in Quality Assurance and/or biologics manufacturing within a large multinational pharmaceutical organization. 10+ years managing a team, preferably global teams covering various countries and time zones. Extensive experience in audit readiness, including HA audit preparation, mock audits, and risk management. Proven expertise in Quality Assurance HA communication and inspection management support for CMO manufacturing at a biologics company. Demonstrated experience overseeing CMOs, understanding expectations, capabilities, and challenges. Experience in formulation bulk, filling and finish, secondary packaging processes, and current industry best practices for visual and automated inspection of materials such as vials, syringes, device delivery systems, and secondary packaging. Expert knowledge of manufacturing and GMP QA requirements for a specific technical area. Proven ability to problem‑solve on quality and supply assurance, including root‑cause identification, preventive actions, and investigations. Ability to conduct knowledge transfer, onboarding, and convening communities of practice. Business‑level English strong in both written and oral communication. Ability to work cross‑functionally and partner with internal and external stakeholders across global regions. Strong risk judgment and ability to elevate issues when needed. Travel Requirements Ability to travel up to 30% of the time globally; flexibility for increased travel depending on manufacturing activity at CMOs. EEO Statement 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 $226,275.00 – USD $377,125.00