Senior Quality Manager CMO – Antibody Drug Conjugate Manufacturing

About the role

Daiichi Sankyo is seeking a Senior Quality Manager to lead quality oversight for Contract Manufacturing Organizations (CMOs) involved in Antibody‑Drug Conjugate (ADC) production. You will act as the primary quality contact, ensuring that all CMO activities comply with Daiichi Sankyo’s GMP/GDP standards and regulatory requirements for oncology products.

Key responsibilities

• Manage quality oversight at CMOs, handling change controls, deviations, and complaints for drug substance (DS) products.
• Define and track effective CAPAs with CMOs, ensuring timely implementation.
• Review, evaluate, and approve quality documents such as APQRs, PPQ reports, and CPVs.
• Prepare, negotiate, and monitor Quality Agreements (QAAs) with CMOs.
• Support establishment of new manufacturing processes, site transfers, and validation activities as a quality subject‑matter expert.
• Assist CMOs during authority inspections and conduct audits on behalf of Daiichi Sankyo.
• Identify and escalate quality risks, act as a global information distributor, and share insights with worldwide QA teams.
• Contribute to the continuous improvement of the corporate quality management system and global SOP landscape.

Required profile

• University or Master’s degree in natural sciences or pharmaceutical sciences.
• Extensive experience in pharmaceutical quality management, preferably in oncology or ADC manufacturing.
• Proven ability to work globally with cross‑functional teams such as Supply Chain, CMC, and Regulatory.

Required skills

• Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) knowledge.
• CAPA management.
• Process validation and PPQ expertise.
• Audit and inspection experience.
• Quality Agreement (QAA) negotiation.