Head of Quality Assurance, Drug Product, GMP QA

Location: Basking Ridge

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. The role is responsible for inspection performance/readiness activities, data integrity and accountable to ensure final batch disposition and lot release activities to support patient needs/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 Quality Operational Oversight and Leadership Leads a team of 5-7 MSMQ’s that are responsible for leading an 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 issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval Ensure the local QMS remains fully compliant with the global Quality Manual by managing key pillars such as CAPA, change control, and data integrity.

Use a risk-based approach to drive periodic reviews and maintain rigorous policy oversight. Provide hands-on leadership to ensure the seamless execution of Quality Assurance (QA) functions, including complaint management, root-cause investigations, and the 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 a culture of Continuous Improvement (CI) across the site, spearheading initiatives to systematically reduce deviations, shorten manufacturing cycle times, and enhance the robustness of the CAPA (Corrective and Preventive Action) system. Supports the enhancement of a robust Integrated Risk Management (IRM) framework, identifying potential risks throughout the product lifecycle and implementing proactive mitigation strategies to ensure patient safety and product efficacy.

Represent Quality Assurance in internal and (potentially) external leadership forums and strategic initiatives. Compliance & Regulatory Affairs Drive institutional adherence to international regulatory frameworks, overseeing the implementation of quality policies that satisfy both domestic and global health authority requirements including but not limited to: cGMP, FDA, EMA, ANVISA, PMDA and ICH guidelines. Comfortable representing the company to health authorities and expertly navigate difficult audit dynamics with global regulators, ensuring the company’s compliance posture is defended and accurately communicated.

The role includes working cross-functionally with product quality counterparts to ensure an accurate Clinical Trial Document review process People & Culture Propose resource allocation and MSMQ deployment to Global Manufacturing…