Senior Manager Production Excellence & Operational Support

Responsibilities

• Plan, manage, and take responsibility for complex validation projects, including manufacturing, cleaning, and aseptic production processes
• Oversee qualification strategies (PQs) and their implementation within the production environment
• Lead the investigation of complex deviations, including systemic root-cause analysis and the development of sustainable CAPA strategies
• Act as a Subject Matter Expert (SME) during regulatory inspections, presenting and defending technical concepts
• Manage change control processes and optimize manufacturing processes from economic, technological, and GMP perspectives
• Drive the definition and harmonization of SOPs and GMP standards across multiple production areas
• Lead cross-functional projects and provide technical leadership and coaching to team members
• Manage stakeholder relationships with global functions and external partners

Requirements

• Degree in Pharmacy (Approbation) is required; a PhD is preferred
• 5+ years of experience in pharmaceutical manufacturing
• 3+ years of experience in pharmaceutical manufacturing specifically including project management and GMP responsibility
• Proven experience in biopharmaceutical API manufacturing
• Deep GMP expertise, including familiarity with EU-GMP, FDA, and EMA guidelines
• Experience working with Single-Use materials
• Fluent English communication skills (business level)

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 inclusion to shape a healthier future for patients worldwide.