Senior Manager Quality and Operations Analytics

• Supporting GMP/GDP/MDR quality oversight for C(D)MOs, test laboratories, medical device suppliers, packagers, and carriers.
• Assisting in the tech transfer of analytical methods and ensuring GMP-compliant execution.
• Providing quality support for programs transitioning from development to commercial production.
• Managing events such as OOS, OOT, and OOE.
• Handling QC changes and related CAPAs.
• Coordinating with business units, production areas, and suppliers on events, changes, and CAPAs.
• Leading continuous improvement measures for quality-relevant processes of commercial pharmaceuticals.
• Ensuring inspection readiness and accompanying internal and external audits.
• Collecting key quality/compliance indicators for periodic review of the local QMS.
• Monitoring quality systems for trends and informing management of relevant events.

• BA/BS, MA/MS, or PhD in a technical or engineering discipline or a related field.
• At least 4 years of experience in a quality function with increasing responsibility in the biotech, life sciences, or pharmaceutical industry.
• In-depth knowledge of analytical sciences for biologics.
• Understanding and interpretation of ISO 9001, ISO 13485, as well as ICH Q8, Q9, and Q10.
• Knowledge of cGMP and GDP requirements for pharmaceuticals and combination products, including biologics.
• Familiarity with GMPs and best quality practices in biotechnological manufacturing processes.
• Experience in dealing with regulatory bodies, e.g., FDA and EMA.
• Proven success in third-party quality management.
• Excellent English skills, both spoken and written; French skills are an advantage.
• Strong leadership capabilities alongside drive, intensity, and enthusiasm.

• Highly diverse range of responsibilities.
• Comprehensive training and development
• Personal development and training opportunities.
• International career opportunities
• Reliable employer
• Strong global growth.
• Active health promotion
• Free parking
• Cafeteria
• Joint company events

The advertising company is seeking reinforcement at the Graz, Styria location.

The client is treated confidentially in this process. You will learn the name during the application process.