Gruppenleitung Deviation Management & Operations

Responsibilities

• Take overall responsibility for Deviation, OOX, and CAPA management, as well as Quality Oversight within the eQMS
• Lead the group with responsibility for personnel, resources, prioritization, escalation, and performance management
• Ensure QMS and cGMP compliance in accordance with EU-GMP, ICH, FDA, and EMA guidelines
• Evaluate, investigate, and close deviations, including root cause analysis and effectiveness reviews
• Monitor KPIs and trends, including reporting and deriving necessary improvement measures
• Manage shopfloor activities and drive continuous improvement of GMP compliance
• Represent the department during audits and inspections
• Create and review SOPs and participate in global best-practice exchanges

Requirements

• Degree in Pharmacy or Natural Sciences
• Proven leadership experience (disciplinary and/or functional) in a regulated environment, including building and developing high-performing teams
• Extensive experience in a GMP environment and Quality Assurance, ideally focusing on deviation/investigation/OOX processes and CAPA management
• Comprehensive knowledge of GMP guidelines for relevant markets (EU, US, and JP)
• Proficiency in MS Office applications and experience with SAP, LIMS, or electronic Quality Management Systems such as TrackWise or Veeva

Benefits

• Attractive compensation and 30 days of vacation
• Company pension scheme and various insurance options (disability, accident, and long-term care)
• Professional development and training opportunities
• Subsidized canteen, health and sports programs, and travel allowances
• Employee discounts and stock programs
• Modern working environment with a focus on wellbeing and work-life balance

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything we do. Our mission is to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Our Oranienburg site is a major production hub for solid dosage forms, supplying high-quality medicines to over 65 countries.