QA Shopfloor Manager

Responsibilities

• Provide proactive quality presence on the shopfloor to ensure uninterrupted, compliant manufacturing operations and meeting adherence to schedule
• Act as the primary QA point of contact for production teams enabling fast, informed decision‑making and real‑time issue resolution
• Ensure seamless QA support by coordinating across QA functions to deliver consistent, and efficient quality support to manufacturing and support preparing quality rated answers for customer requests
• Enforce strict adherence to internal procedures and GxP requirements supporting right‑first‑time execution and minimizing delays
• Support investigations into deviations and non‑conformances, ensuring robust root cause analysis, effective CAPA implementation, and timely closure
• Accelerate by facilitating rapid assessments and ensuring high‑quality documentation of quality‑related matters
• Represent QA in daily and weekly shop floor meetings, addressing quality risks and promoting a solutions‑oriented mindset
• Lead and contribute to continuous improvement initiatives that enhance quality performance, reduce waste, and increase operational efficiency
• Foster a culture of ownership and accountability on the shopfloor, where quality, accountability, and continuous improvement is seen as an enabler

• University degree (Bachelor/Master) in Chemistry, Organic Chemistry, Natural Sciences, or a comparable scientific or technical discipline, with relevant experience in the field
• Minimum of 5 years of professional experience in API manufacturing, preferably within a CDMO environment
• Demonstrated expertise in quality assurance, with direct exposure to manufacturing operations
• Strong working knowledge of GMP, regulatory requirements, and ALCOA+ principles
• High level of interest in manufacturing processes and operational QA topics, with a mindset geared toward best practices and modern technologies
• Familiarity with quality systems and documentation processes, including deviation handling, CAPA, and change control
• Experience with or willingness to develop skills in Lean, Six Sigma, or other continuous improvement methodologies
• Proficient in both written and spoken German and English.