Head of Quality Assurance, Drug Product

Job title: Head of Quality Assurance, Drug Product

About the Role 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 and is responsible for an effective, risk-based Quality System, inspection readiness, data integrity, and final batch disposition and lot release 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 provides oversight of manufacturing sites across the product lifecycle, collaborates on PPQ planning, and supports the transition to commercial manufacturing with the product portfolio, while delivering technical expertise to their team of MSMQs.

What You'll Do

• Lead 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 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 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 Quality Head; Partner with HR to oversee talent selection, development, and evaluation of direct reports; Foster a culture of accountability, transparency, and continuous improvement.

What We're Looking For

• Education: Bachelor's Degree in a science-related discipline required. An Advanced Degree strongly preferred.
• Experience: 10+ years of experience in a specific technical area as Quality Assurance and/or biologics manufacturing in a large multinational pharmaceutical organization required; 10+ years of experience managing a team, able to lead across different cultures, build effective teams, and develop talents.
• Must have extensive experience in audit readiness and risk management.
• Proven expertise in Quality Assurance communication, inspection management support for CMO manufacturing at a biologics company.
• Demonstrated experience overseeing CMOs.
• Demonstrated experience in one or more of the following: Formulated Bulk, Filling and Finish, secondary packaging processes, current industry best practices for inspection and their associated materials.
• Must have expert knowledge of manufacturing and GMP QA requirements for a specific technical area.
• Proven ability to problem-solve on quality and supply assurance.
• Ability to conduct knowledge transfer.
• Business level English must be strong both written and oral. Must be able to work cross functionally as a strong collaborator with ability to partner with internal and external stakeholders across multiple global regions.
• Proven ability to use sound risk judgment to escalate issues when needed.
• Travel Requirements: Travel up to 30% of the time globally. Requires flexibility of increased travel dependent on the level/frequency of manufacturing activities at a given CMO.

Nice to Have

• Advanced degree strongly preferred.
• Experience leading globally dispersed teams and cross-cultural leadership.
• Knowledge of Clinical Trial Documentation review processes.