Senior Manager, Global Quality Management System (Global R&D & PV QA)

Daiichi Sankyo Europe

Zurich, Switzerland

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

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