Head of Quality Assurance, Drug Product, GMP QA

Head of Quality Assurance, Drug Product, GMP QA

Daiichi Sankyo Europe

Munich, Germany

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.

Roles and Responsibilities

Quality Operational Oversight and Leadership

• Leads a team of 5–7 MSMQs responsible for leading an independent QA function, with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production in accordance with Daiichi Sankyo’s GMP Quality Manuals.
• Resolves issues related to quality performance at internal and external manufacturing sites escalated by MSMQs through collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalates issues to the GMQ Head as necessary for resolution and approval.
• Ensures the local QMS remains fully compliant with the Global Quality Manual by managing key pillars such as CAPA, change control, and data integrity. Uses a risk-based approach to drive periodic reviews and maintain rigorous policy oversight.
• Provides 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.
• Directs the batch release process by overseeing complex jurisdictional controls and cross-functional data integration, ensuring all disposition decisions align with Daiichi Sankyo’s Quality Digital Roadmap and analytics strategy.
• Drives a culture of Continuous Improvement (CI) across the site by 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 by identifying potential risks throughout the product lifecycle and implementing proactive mitigation strategies to ensure patient safety and product efficacy.
• Represents Quality Assurance in internal and, where applicable, external leadership forums and strategic initiatives.

Compliance & Regulatory Affairs

• Drives institutional adherence to international regulatory frameworks by 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.
• Comfortably represents the company to health authorities and expertly navigates complex audit dynamics with global regulators, ensuring the company's compliance posture is effectively defended and accurately communicated.
• Works cross-functionally with Product Quality counterparts to ensure an accurate Clinical Trial Document review process.

People & Culture

• Proposes resource allocation and MSMQ deployment to the Global Manufacturing Quality Head.
• Partners with HR to oversee talent selection, development, and performance evaluation of direct reports.
• Fosters a culture of accountability, transparency, and continuous improvement.

Education Qualifications

• Bachelor's Degree in a science-related discipline required. An Advanced Degree strongly preferred.

Experience Qualifications

• 10 or more more years of experience in a specific technical area as Quality Assurance and/or biologics manufacturing in a large multinational pharmaceutical organization required.
• 10 or more years of experience managing a team (preferably global teams covering various countries/time zones), being able to lead across different cultures, build effective teams, develop talents required.
• Must have extensive experience in audit readiness (including HA audit preparation, conduct mock audits), and risk management required.
• Proven expertise in Quality Assurance HA communication, inspection management support for CMO manufacturing at a biologics company required.
• Demonstrated experience overseeing CMOs (including understanding CMO expectations, capabilities, and challenges) required.
• Demonstrated experience in one or more of the following: Formulated Bulk, Filling and Finish, secondary packaging processes, current industry best practices for inspection (visual and automated) and their associated materials (e.g. Vials, Syringes, Device Delivery systems, secondary packaging) required.
• 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 (including root cause identification and analysis, preventive actions and investigation).
• Ability to conduct knowledge transfer (including transfer of institutionalized knowledge, setting up formal structures, onboarding, convening communities of practice, ensuring access to expertise).
• 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.
• Proen abiity to use sound risk judgment to escalate issues when needed.

Travel Requirements

• Ability to travel up to 30% of the time globally.
• Requires flexibility of increased travel dependent on the level of frequency of manufacturing activities at a given CMO.