Corporate responsibility manager Jobs in Alsdorf

Your challengesThe Head of Global Quality Management and Regulatory Affairs Bioprocess is responsible for the strategic and operational Bioprocess Quality Management System and regulatory compliance, including : Ensure and further develop compliance regarding ISO 9001, 13485, GMP and potentially US FDA 21 CFR Part 820 of the company in the QM matrixDriving the development of the global Bioprocess Quality and RA strategy as well as targetsEstablishment and development of the Customer / Case Management processManaging 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 environmentLeading, developing the global Bioprocess quality team incl. all related budget responsibilitiesQuality ManagementResponsible 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 RegulationBeing 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 satisfactionProvide quality and process related trainingConduct internal functional / organizational Audits as well to interfaces like Sales & Service organization, Competence Center and supplier, distributorEstablish and monitor KPI performance including data collection and providing reports to the managementComplaint ManagementEstablishment and development of the Customer / Case Management processAs Complaint Management process owner monitor the uniformity of the complaint management process and analyze the effectiveness and identify improvement opportunitesPrepare 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 customersSupport in the design and implementation of the company-wide data management strategy in Customer Complaint ManagementCAPA ManagementAs process owner of Non-Conformance Process establish and monitor a Bioprocess Eppendorf group wide harmonized processBuild-up competence of resources within Bioprocess that reasonable and effective executes CAPA, NCEnsure timely and compliant execution of corporate NCs, CAPAs by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolutionProvide tracking reports for NC, CAPA and Corporate Complaint InvestigationsRegulatory AffairsProvide regulatory input to new product development and product lifecycle planning for our Bioprocess productsDevelop 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)Compile, prepare, review and submit regulatory submissions to authorities in cooperation with local country / Regional Regulatory Affairs colleaguesAnticipate regulatory obstacles and emerging issues throughout the product lifecycleMonitor validiy of licenses, registrations and listings and renew in timeDrive the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global Bioprocess QM / RA groupLeadership / people managementManage efficiently and motivate cross-functional and intercultural teams (direct and indirect reports)Establish individiual goals and expected levels of performance, evaluate performance, give feedback and provide people development measures (e.g. training, coaching) where neededSupport 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 strategyInitiate and realize the change process (behaviour, mindset), being a role modelYour expertiseDeep knowledge in Q-Systems ISO 9001, 13485, GMP,  beneficial experiences with UD FDA 21 CFR Part 820 Quality Systems RegulationAt least 10 years of experience in the Life Science or Medical Device industryMany years of experience in the design and implementation of QM systems und business processesDegree in engineering in natural sciences or comparable technical educationFluent in German and EnglishLife science / Medical device Industry experienceStrong interpersonal skills, ability to collaborate and network effectivelySummaryLocation : Jülich (DASGIP)Type : Full time