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.
Purpose of the function
LOCATION: SWITZERLAND
The Manager, Global Quality Management System (Global RandD and PV QA), supports the oversight and continuous improvement of Daiichi Sankyo's QMS, including Master Data/Data Lake reporting, Veeva Quality Docs management, Global SOP governance, training management, quality metrics, and inspection support. The role ensures that GxP procedural documents, training frameworks, and reporting processes comply with global regulatory requirements and Daiichi Sankyo policies, while driving harmonisation and continuous improvement across R&D, PV, MA, a
Roles and Responsibilities
CoMET Quality Docs Vault Management
Provide system and process support, including:
- Supporting the review, approval, and publication of GxP procedural documents in the CoMET QualityDocs Vault.
- Acting as Subject Matter Expert (SME) for the electronic document management system, contributing to system requirements and configuration.
- Reviewing and executing User Acceptance Testing (UAT) scripts for document management system changes.
- Ensuring document lifecycle activities comply with global quality and system governance requirements.
Global SOP Committee (GSOPC) Office Activities
- Providing QA oversight and coordination for GSOPC office activities.
- Facilitating timely review and approval of Global RandD, Pharmacovigilance, and Medical Affairs procedural documents.
- Overseeing Global SOP lifecycle management and maintaining appropriate document controls.
- Monitoring new and revised GCP/GLP/GVP regulatory requirements and supporting impact assessments, SOP updates, training, and QMS process changes.
- Developing collaboration tools and coordinating GSOPC meetings and sub meetings.
- Collaborating with global, regional, and local functions to ensure procedural alignment.
- Participating in cross functional QMS and continuous improvement initiatives.
Training Management
- Serving as the global training lead in collaboration with Global QA and partner functions.
- Supporting the development and maintenance of GxP training strategies, processes, programmes, and systems to ensure regulatory and policy compliance.
- Managing the QA training framework and infrastructure across GxP regulated areas.
- Supporting global communications and change management for procedural and training updates.
- Participating in cross functional QMS and continuous improvement initiatives.
Metrics and Reporting
- Supporting Master Data/Data Lake reporting initiatives and the development of RandD, CSPV, and MA quality metrics aligned with Health Authority expectations.
- Preparing operational reports and dashboards for SOP lifecycle management and QMS performance.
- Partnering with DSI and global functions to address emerging issues and drive continuous improvement.
- Ensuring metrics align with regulatory requirements and industry best practices.
Inspection Support
- Representing Daiichi Sankyo during regulatory inspections, partner audits, and internal audits, as required.
- Responding to inspection and audit inquiries related to GxP procedural documents and QMS processes.
- Supporting CAPA development, implementation, and follow up related to inspections and audits.
- Ensuring procedural documentation is inspection ready and reflects current operational practices.
Further Roles and Responsibilities
Education & Experience
Education
- Bachelor’s degree in Life Sciences, Pharmacy, IT, or related field required.
- Master’s degree or higher preferred.
Experience
- 5–8 years of experience in Quality Assurance and/or regulated pharmaceutical environments supporting R&D, Pharmacovigilance, and Medical Affairs.
- Strong knowledge of FDA and other global regulatory requirements; experience engaging with regulatory agencies preferred.
- Experience participating in or leading global projects within matrixed organisations. • Knowledge of SDLC and implementation of electronic Quality Systems.
- Experience developing operational reports, dashboards, and quality metrics.
Skills and additional Requirements
- Ability to critically review procedural documents and provide value added input.
- Strong project management and stakeholder engagement skills.
- Effective and influential communicator across diverse cultures and global teams.
- Strong understanding of regulatory impact on pharmaceutical operations.
- Data driven mindset with a focus on compliance excellence and continuous improvement.
