At Daiichi Sankyo, we are united behind a single goal: to improve lives around the world through innovative medicines. With active innovation since 1899, a presence in more than 30 countries, and over 19,000 employees, we develop groundbreaking therapies in oncology, cardiovascular diseases, rare diseases, and immune disorders. In line with our Vision 2030, "to be an innovative global healthcare company that contributes to the sustainable development of society," we are creating a healthier, more hopeful future for patients, their families, and society. 

The position:

We are immediately seeking a dedicated individual for our location in Pfaffenhofen.

Senior Manager Production Coordination & Projects (m/f/d)

Details of the activity:

• Comprehensive deputization of the head of production in operational and cross-cutting issues, as well as active support in day-to-day business.
• Assumption of responsibilities in accordance with Section 13 AMWHV in the absence of the head of production
• Control and prioritization of cross-functional issues within production
• Central interface between pharmaceutical production, QC, QA, manufacturing site management and other functions for complex or critical issues.
• Responsibility for the further development and management of GMP governance systems in the production area in close coordination with QA
• Leading role in the preparation, coordination and execution of inspections and audits (including representing the department)
• Management and control of projects with high relevance for the production area (e.g. investment, compliance, validation/qualification or transformation projects as needed)
• Close involvement in key projects managed by the head of production and assumption of significant partial responsibility
• Independent handling of complex / critical deviations and complaints in close coordination with the head of production.
• Definition, harmonization and further development of overarching standards and processes within production
• Coordination and control of capacity planning, forecasts and cross-departmental coordination
• Supporting the head of manufacturing with organizational and process strategies

Professional and personal requirements:

• Completed studies in pharmacy (license to practice)
• > 5 years of relevant experience in pharmaceutical manufacturing or a PhD in a core pharmaceutical subject and > 3 years of experience in pharmaceutical manufacturing, including project management and GMP responsibility
• In-depth GMP expertise (e.g., EU-GMP, AMWHV, 21CFR, EMA and FDA guidelines, PDA) including interpretation of regulatory requirements
• Broad understanding of pharmaceutical production and related functions
• Experience in dealing with complex deviations and inspection situations
• Experience in managing complex, cross-functional issues
• Very strong organizational and prioritization skills
• High decision-making certainty and assertiveness
• Strong communication and stakeholder management skills (also internationally)
• Ability to prepare and represent topics at a management level
• Excellent English skills (fluent in negotiations)
• Leadership skills (professional)
• Ability to set standards and shape organizations
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