Your challenges
* The Head of Global Quality Management and Regulatory Affairs Bioprocess is responsible for the strategic and operational Bioprocess Quality Management System and regulatory compliance, including:
o 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
o Driving the development of the global Bioprocess Quality and RA strategy as well as targets
o Establishment and development of the Customer/Case Management process
o 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
o Leading, developing the global Bioprocess quality team incl. all related budget responsibilities
* Quality Management
o 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
o Being the representative of the Bioprocess Quality Department towards external Authority inspections and client audits (Management Representative acc. to 13485)
o Proactively provides leadership in Bioprocess Quality System definition and deployment with focus on prevention, continuous improvement programs, and customer satisfaction
o Provide quality and process related training
o Conduct internal functional/organizational Audits as well to interfaces like Sales & Service organization, Competence Center and supplier, distributor
o Establish and monitor KPI performance including data collection and providing reports to the management
* Complaint Management
o Establishment and development of the Customer/Case Management process
o As Complaint Management process owner monitor the uniformity of the complaint management process and analyze the effectiveness and identify improvement opportunities
o Prepare reporting for internal review meetings (create reports, pattern search, trend identification)
o 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
o Support in the design and implementation of the company-wide data management strategy in Customer Complaint Management
* CAPA Management
o As process owner of Non-Conformance Process establish and monitor a Bioprocess Eppendorf group wide harmonized process
o Build-up competence of resources within Bioprocess that reasonable and effective executes CAPA, NC
o Ensure timely and compliant execution of corporate NCs, CAPAs by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution
o Provide tracking reports for NC, CAPA and Corporate Complaint Investigations
* Regulatory Affairs
o Provide regulatory input to new product development and product lifecycle planning for our Bioprocess products
o Develop multi-country regulatory strategies with regard to the customer target market, which is based on the requirements of internationally recognized quality standards of pharma/biotech (GMP)
o Compile, prepare, review and submit regulatory submissions to authorities in cooperation with local country/Regional Regulatory Affairs colleagues
o Anticipate regulatory obstacles and emerging issues throughout the product lifecycle
o Monitor validity of licenses, registrations and listings and renew in time
o Drive the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global Bioprocess QM/RA group
* Leadership/people management
o Manage efficiently and motivate cross-functional and intercultural teams (direct and indirect reports)
o Establish individual goals and expected levels of performance, evaluate performance, give feedback and provide people development measures (e.g. training, coaching) where needed
o Support all Human Resources processes and procedures to ensure compliant and engaged region, participate in developing compensation and people development plans in line with the company strategy
o Initiate and realize the change process (behaviour, mindset), being a role model
Your expertise
* Deep knowledge in Q-Systems ISO 9001, 13485, GMP, beneficial experiences with UD FDA 21 CFR Part 820 Quality Systems Regulation
* At least 10 years of experience in the Life Science or Medical Device industry
* Many years of experience in the design and implementation of QM systems and business processes
* Degree in engineering in natural sciences or comparable technical education
* Fluent in German and English
* Life science/ Medical device Industry experience
* Strong interpersonal skills, ability to collaborate and network effectively
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