Senior Manager Audit & Supplier Qualification

Responsibilities

• Plan and perform GMP/GDP audits at Contract Manufacturing Organizations (CMOs) and suppliers
• Prepare audit findings and reports, discussing potential business impacts with stakeholders
• Manage follow-up communication regarding audits and monitor CAPA implementation
• Provide internal consultation for risk identification related to CMOs and suppliers
• Support the definition and negotiation of global and regional Quality Agreements
• Support integrated risk management activities, including risk evaluation and scorecarding
• Assist with due diligence activities

Requirements

• Degree in Pharmacy, Biology, Chemistry, or a comparable scientific discipline
• 5-8 years of professional experience in a pharmaceutical company within the GMP area
• Extensive knowledge of international guidelines such as EudraLex Vol. 4, CFR 201/211, and GAMP
• Proven experience in supplier qualification and acting as a Lead Auditor
• Proficiency in TrackWise Digital or comparable QMS IT systems
• Fluency in English (both spoken and written)
• High willingness to travel is an essential requirement

Preferred Qualifications

• Auditor certification (e.g., CQI/IRCA, ASQ)
• Additional experience with ISO 9001 or DIN norms
• Experience in both sterile and non-sterile pharmaceutical manufacturing

About the Company

Daiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. With a presence in more than 30 countries, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. We foster a culture of mutual respect, continuous learning, and a strong commitment to inclusion and diversity.