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 Senior Manager is accountable for end to end global oversight, governance, and continuous improvement of the GCP/GLP/GVP Vendor Quality Programme across Daiichi Sankyo group companies.This role provides strategic leadership and subject matter expertise to ensure consistent, risk based vendor qualification, oversight, and compliance for all critical external vendors supporting RandD, Pharmacovigilance, and Medical Affairs.The role operates with a high degree of autonomy, acts as a key partner to global stakeholders, and plays a critical role in inspection readiness, regulatory credibility, and patient safety.
Roles and Responsibilities
Global Vendor Quality Governance and Programme Leadership
- Own and continuously enhance the global GCP/GLP/GVP Vendor Quality framework, policies, and standards.
- Ensure consistent, risk based implementation across regions, functions, and subsidiaries. c. Serve as a global decision authority for complex or high risk vendor quality matters
Vendor Qualification, Risk Management and Oversight
- Lead and govern the qualification and lifecycle management of global GxP vendors, including CROs, laboratories, PV service providers, and GxP IT/system vendors.
- Define and approve risk based vendor categorisation, qualification strategies, and oversight models.
- Ensure the global approved vendor list remains current, compliant, and inspection ready.
Vendor Audits and Regulatory Inspection Readiness
- Provide strategic input and leadership to global vendor audit planning and execution in collaboration with Audit and Compliance.
- Act as a recognised SME for vendor quality during internal audits and Health Authority inspections (FDA, EMA, PMDA, etc.).
- Lead remediation strategy, impact assessments, and executive communication for vendor related inspection findings.
Quality Agreements and Cross Functional Alignment
- Ensure robust Quality Assurance Agreements are established, maintained, and aligned with regulatory and business requirements for all critical vendors.
- Partner closely with Legal, Procurement, IT, and Business Functions to resolve complex contractual and compliance issues.
- Drive alignment between quality requirements and business realities while maintaining regulatory integrity.
Performance Monitoring, Metrics and Reporting
- Define, review, and interpret vendor quality KPIs and quality metrics.
- Provide clear, risk focused insights and recommendations to senior leadership.
- Use data to support decision making, prioritisation, and continuous improvement.
Continuous Improvement and Capability Building
- Lead global initiatives to simplify, standardise, and mature vendor quality processes.
- Monitor regulatory trends and industry best practices; translate them into practical, scalable improvements.
- Mentor and provide technical guidance to team members and stakeholders to build global vendor quality capability.
Key Deliverables
- Sustained inspection ready status of the global GCP/GLP/GVP vendor portfolio.
- Timely, risk based vendor qualification and re qualification with complete, compliant documentation.
- No critical or systemic vendor related findings in audits or regulatory inspections.
- Effective, globally aligned Quality Agreements for all critical vendors.
- Actionable vendor quality metrics supporting executive oversight and decision making.
- Measurable improvements in vendor quality processes, efficiency, and risk management.
- Sustained inspection ready status of the global GCP/GLP/GVP vendor portfolio.
- Timely, risk based vendor qualification and re qualification with complete, compliant documentation.
- No critical or systemic vendor related findings in audits or regulatory inspections.
- Effective, globally aligned Quality Agreements for all critical vendors.
- Actionable vendor quality metrics supporting executive oversight and decision making.
- Measurable improvements in vendor quality processes, efficiency, and risk management.
Further Roles and Responsibilities
Education & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field
- Minimum 8-10 years of relevant experience in Quality Assurance and/or Clinical Development within pharma/biotech, including a minimum of 5 years in GCP/GLP/GVP vendor quality management.
- Demonstrated experience leading global vendor quality programmes, not just executing activities.
- In depth, practical knowledge of global GxP regulations and guidance (FDA, EMA, PMDA, ICH, GDPR, GAMP 5, 21 CFR Part 11)
- Strong experience supporting regulatory inspections and managing vendor related CAPAs.
- Experience working effectively in global, matrixed, and hybrid environments.
- Familiarity with eQMS systems (e.g. TrackWise) and digital/AI enabled ways of working.
Skills and additional Requirements
- Executive level written and verbal English communication
- Strong leadership presence with the ability to influence without authority.
- Strategic mindset with excellent judgement in complex, ambiguous situations.
- Proven ability to lead cross functional and cross regional initiatives independently.
- Strong negotiation, conflict resolution, and change management skills.
- Detail oriented with a continuous improvement mindset.
