(Senior) Manager Quality Operations Analytics (m/f/d)

Your tasks

• Support GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers
• Support Tech Transfer of Analytical Method and provide Quality Oversight for GMP compliant execution
• Provide quality support to programs ensuring smooth transition from development to commercial
• Manage Events (OOS/OOT/OOE), Changes (QC), related CAPAs liaising with the relevant functions of the Business Unit, Production Units (PUs) and Suppliers
• Lead continuous improvement of quality processes associated to commercial medicinal products, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls
• Collect Key Quality/Compliance Indicators for periodic review of local Quality Management System
• Monitor Quality Systems for trends and notify management of events requiring and immediate action

Our expectations

• A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
• Minimum 4 years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
• Strong background in analytical sciences for biologics
• Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP & GDP requirements for Pharmaceuticals and Combination Products, including Biologic Products
• Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
• Experience with regulatory agencies such as the FDA, EMA, etc
• Proven success in third-parties’ quality management
• Excellent communication skills in English, both written and oral, French as an asset
• Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm

We offer

• Highly varied range of tasks
• Training opportunities and personal development within the company
• Career opportunities in an international pharmaceutical company
• Attractive, performance-based remuneration (minimum gross annual salary of € 60,000; higher salary depending on qualifications)