Senior Quality Assurance Manager

Quality Assurance Manager (GMP, Sterile Manufacturing)

On-site, Stein

About the Role

Join a high‑impact QA team ensuring GMP compliance in one of Europe’s most advanced sterile manufacturing environments. In this role, you act as key QA partner for operations, projects and continuous improvements.

Key Responsibilities

• Act as QA Single Point of Contact for assigned operations and projects
• Review and approve GMP documentation including SOPs, deviations, CAPAs and change controls
• Ensure compliance of sterile manufacturing processes in alignment with cGMP
• Support investigations and root cause analysis activities
• Contribute to internal/external audits and inspections
• Provide QA oversight to 41X Growth Projects
• Drive improvements in quality systems and operational processes
• Track and report Quality KPIs
• Collaborate with internal stakeholders and external partners

Requirements

• Master’s or PhD in Chemistry, Biology, Pharmacy or related field
• 5–10 years of QA/QC experience in GMP pharmaceutical manufacturing
• Strong understanding of cGMP for sterile production
• Excellent problem‑solving and prioritization skills
• Fluent in English; German is beneficial

Core Competencies

• Agility and openness to change
• Cross-functional collaboration
• Customer focus and stakeholder management
• Strong results orientation
• Leadership mindset and accountability

What We Offer

• Work in a cutting-edge sterile manufacturing environment
• Key role with direct impact on product quality and patient safety
• Development opportunities across a global QA network
• Stable and highly respected employer in the Life Sciences industry