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.
The Position:
The Senior Manager, Global Quality Management System (Global R&D and PV QA) serves as a global QMS domain leader and Subject Matter Expert (SME) responsible for ensuring that GCP/GLP/GVP processes, SOPs, and QMS frameworks are globally harmonised, inspection-ready, and aligned with evolving regulatory expectations. This role provides end-to-end ownership of key QMS elements, including SOP governance, training, inspection readiness, and quality metrics, while driving cross-functional alignment across R&D, PV, Medical Affairs, and Regulatory. It acts as a primary liaison for inspections/audits and regulatory intelligence integration, and actively leads continuous improvement initiatives based on audit trends, metrics, and emerging regulatory requirements..
Roles and Responsibilities:
Global QMS Process Ownership and Implementation:
- Serve as global process owner and SME for assigned QMS domains (e.g., GSOP governance, document management, training framework, metrics)
- Lead end-to-end SOP oversight, ensuring procedures are globally harmonised, cross-referenced and consistent, and compliant with GCP/GLP/GVP and international regulatory standards
Global SOP Committee (GSOPC) and Governance Leadership:
- Provide strategic oversight and operational leadership for GSOP Committee (GSOPC) activities
- Ensure efficient SOP lifecycle management, timely approvals and publication, and cross-functional governance alignment
- Lead global collaboration across regions and functions to ensure procedural consistency
Training Strategy and Capability Building:
- Act as global training lead, responsible for defining the QMS training strategy, driving inspection readiness training programmes, and ensuring alignment with regulatory expectations
- Develop and deliver GCP/GLP/GVP and inspection readiness training in collaboration with Functional QA
- Lead change management and communication strategies for procedural updates
Quality Metrics, Data Analytics, and Continuous Improvement:
- Lead development and oversight of global QMS metrics and dashboards, ensuring alignment with regulatory expectations
- Analyse audit findings, inspection trends, and quality metrics to identify systemic risks and improvement opportunities
- Drive continuous improvement initiatives at global level
Regulatory Inspection, Audit, and Compliance Leadership:
- Serve as primary QMS liaison for regulatory inspections and audits (FDA, EMA, PMDA, NMPA, etc.)
- Lead inspection readiness strategy, preparation activities and documentation alignment, and inspection participation and response coordination
- Provide expert input into CAPA development and effectiveness verification, ensuring sustainability of corrective actions
Regulatory Intelligence and Strategic Integration:
- Partner with Regulatory Affairs to monitor global regulatory developments (GCP/GLP/GVP) and assess impact on QMS processes
- Lead integration of new regulations into SOPs, training, and QMS frameworks
Personal Skills and Professional Experience:
Education:
- Bachelor's degree in Life Sciences, Pharmacy, IT, or a related field required
- Master's degree or higher preferred
Experience:
- 8–12 years of relevant GxP QA experience, including global QMS implementation and governance, SOP oversight and harmonisation, and inspection and audit leadership
- Demonstrated experience in regulatory inspections (FDA/EMA/PMDA/NMPA), CAPA management and effectiveness, and cross-functional global projects
- Strong knowledge of ICH, GCP/GLP/GVP frameworks, and global regulatory requirements
Competencies:
- Strong subject matter expertise in global QMS and regulatory compliance
- Strategic thinking with data-driven decision-making capability
- Proven ability to lead in a global matrix environment and influence stakeholders
- Excellent communication skills across functions and regions
- Ability to drive continuous improvement and organisational alignment
