Job am 13.01.2025 bei Jobleads gefunden
Head of Global Quality Management Regulatory Affairs Bioprocess (m/w/d)
• Jülich, Nordrhein- Westfalen
Führungs-/ Leitungspositionen
[...] Ensure and further develop compliance regarding ISO 9001, 13485, GMP and potentially US FDA 21 CFR Part 820 of the company in the QM matrix. Driving the development of the global Bioprocess Quality and RA strategy as well as targets.
Establishment and development of the Customer/ Case Management process. Managing the Bioprocess Quality Manager and Regulatory Affairs Manager in the respective area of responsibility including direct and indirect responsibility for employees which will operate within a matrix environment. Leading, developing the global Bioprocess quality team incl. all related budget responsibilities. Quality Management Responsible for implementing and maintaining the effectiveness of the quality management system according to ISO 9001, 13485, GMP and US FDA 21 CFR Part 820 Quality Systems Regulation. Being the representative of the Bioprocess Quality Department towards external Authority inspections and client audits (Management Representative acc. to 13485) . Proactively provides leadership in Bioprocess Quality System definition and deployment with focus on prevention, continuous improvement programs, and customer satisfaction. Provide quality and process related training. Conduct internal functional/ organizational Audits as well to interfaces like Sales
Service organization, Competence Center and supplier, distributor. Establish and monitor KPI performance including data collection and providing reports to the management. Complaint Management Establishment and development of the Customer/ Case Management process. As Complaint Management process
owner monitor the uniformity of the complaint management process and analyze the effectiveness and identify improvement opportunities. Prepare reporting for internal review meetings (create reports, pattern search, trend identification) . Work closely with the Product Management, Production and Service teams to prioritize and answer the most important questions where our product and service performance will have impact to our customers. Support in the design and implementation of the company-wide data management strategy in Customer Complaint Management. CAPA Management As process owner of Non-Conformance Process establish and monitor a Bioprocess Eppendorf group wide harmonized process. Build-up competence of resources within Bioprocess that reasonable and effective executes CAPA, NC. Ensure timely and compliant execution of corporate NCs, CAPAs by driving cross-collaboration across functions, [...] sells instruments, consumables, and services for liquid-, sample-, and cell handling in laboratories worldwide. Eppendorf products are used in academic and commercial research laboratories, e. g. , in companies from the pharmaceutical and biotechnological as well as the chemical and
food industries. Working at Eppendorf means being part of a community of more than 5, 000 scientists, engineers as well as specialists from many other disciplines across more than 30 countries. All of us are committed to one mission: Being the expert partner and advisor of choice for life sciences laboratories around the world-with our premium products, our services, and our reliability. #J-18808-Ljbffr 30373453 [...]
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