Quality Manager, Capa And Qms Systems
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services to our customers and help them work, faster and safer, leading to better patient outcomes.
We are looking for a CAPA AND QMS SYSTEM MANAGER to work with our expert Quality and Regulatory Affairs team of over 200 employees across the world. Do you have a passion for Quality Assurance? Then we would love to hear from you.
What you'll do
Provide global CAPA ownership and process support to the entire Cytiva Quality Organization in accordance with documented policies and procedures
Responsible for the development, implementation and improvement of CAPA work instructions, ensuring compliance with Cytiva QMS
Functional ownership and governance of the Cytiva electronic QMS solution.
Develop, implement, and continuously improve overall CAPA process effectiveness and efficiency
Own the global CAPA process and program, ensuring individual projects are completed on time as agreed with stakeholders. Escalate any issues affecting timeliness or effectiveness of CAPA
Oversee global CAPA and Change Control activities for continuous improvement of validated digital processes and tools
Investigate, develop and propose effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program), through detailed analysis for deviations, non-conformances, and complaints
Monitor CAPA relevant KPI and Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Lean Six Sigma
Act as a subject matter expert of CAPA process, educate/train/coach CAPA owners
Represent the quality function in regulatory and customer audits
Own the generation, maintenance and reporting of global CAPA related metrics and dashboards derived from relevant electronic CAPA systems and tools
Educate, train and coach site QA leadership in generation, maintenance and reporting of site and franchise relevant metrics
Interface with Cytiva global and site leadership on various initiatives and metrics reporting
Who you are
Bachelor's Degree or a minimum of 10 years work experience in a regulated medical device or pharmaceutical industry. Desired: Master's Degree or PhD in Engineering or Technical Discipline
Experienced in leading and implementing change such as implementation of electronic QMS
Proven track record in coaching teams and individuals in quality processes
Experienced in performing internal and external audits.
Exceptional analytical, problem solving & root-cause analysis skills.
Excellent communication skills (written and oral)
Experienced in managing project teams and working cross - functionally and at global level
Understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies
Demonstrated expertise to effectively communicate within all levels of the organization around concepts Corrective & Preventive Action (CAPA), product quality improvement using tools such as six sigma, etc.
Demonstrated collaboration & conflict resolution skills
Please submit your application in English!
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you'll feel right at home here. If you're flexible, curious and relentless, you'll belong. If you are excited about a global culture, this can be the place to further your career.
Publiceringsdatum2020-04-28Så ansöker duSista dag att ansöka är 2020-05-17
Klicka på denna länk för att göra din ansökanAdressGE Healthcare Bio-Sciences AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare GE Healthcare Bio-Sciences AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Jobbnummer 5205606
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