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Danaher Corporation
,
Cardiff, South Glamorgan
EMEA SERVICE QA LEADER
Overview
Job Description
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 tracing back hundreds of years, 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 - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes. We are looking for a EMEA SERVICE QA LEADER to work with our expert Services team of 800 employees across the world. What you'll do + This position is responsible for leading QA support & compliance activities for EMEA region for Global services, reporting to global Service QA Director. He/she represents Cytiva to external agencies and champions the evolution of the quality culture for the function which includes executing and driving site quality objectives, metrics, reporting and operating mechanisms. This role is also responsible for completing and maintaining oversight of both supplier and customer related activities including but not limited to document control, compliance training, SCAR management, customer interactions, complaints and CAPA management. + Drive on-time closure of customer feedback, Investigation and CAPA etc. through regular business touch points, such as CHU, CAPA Board, Ops Review & Quality Council etc. As well as supporting internal external audit and QMR. + Lead process standardization and improvement with Service teams, such as Qualification Service, Customer Bioprocess Service, Goldseal, Global Service Engineering and repair depot etc. + Responsible for leading the development of changes to the Services quality management system in line with business strategic priorities. Educate & drive implementation of new QMS requirements/priorities from business or corporate. Drive a continuous improvement culture based on data trends and promote customer satisfaction culture + Influences product compliance, process development and new product introduction (NPI) including automation software. Support ad-hoc assignment based on business needs, including domestic and/or international travel request. Preferred location for this opening are our Swedish locations in Uppsala or Umea. Cardiff and Amersham in the UK are optional locations. Who you are + Bachelor's degree, plus 5 years QA working experience as supervisor or management and understanding of product development, manufacturing, quality control and servicing in a pharmaceutical or medical device environment. + Demonstrated validation experience in pharmaceutical or medical device industry. + Hands-on experience with FDA, QSR, ISO(ISO9001/ISO13485), MDD and /or other international quality systems requirements, plus audit experience + Strong presentation skill and data analysis skill using word processing, spreadsheet, and other data analyzing tools. + Ability to multi-task & handle tasks with competing priorities effectively, as well as exercising collaboration, negotiation & conflict resolution skills + Proven mentoring and coaching abilities to motivate & inspire others by effective interpersonal, teamwork & networking skills + Digital QMS experience would be an advantage. 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. Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page! Cytiva is a 3.3 billion USD global life sciences leader with nearly 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients. Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.