QA Director, Global Services
Cytiva Sweden AB / Chefsjobb / 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 an experienced QA Director to lead a small global team and being responsible for the monitoring & continuous improvement of the Quality Management system (QMS). You will collaborate closely with Global Services & QA site leadership at each of the Cytiva manufacturing locations to ensure timely responses to Customer Feedback. This role will report directly to the business QA executive.
Do you have a passion for Quality Assurance and leading a Global team? Then we would love to hear from you.
What you'll do
Provide leadership and oversight to ensure QMS procedures, work instructions, and QMS IT System effectively support the Cytiva Global Services organization
Lead a global team of 4 QA professionals being located in the US, Europe and Asia
Coach/mentor direct staff & Cytiva associates on QMS requirements
Understand external requirements and expectations, user and business needs and take proactive measures to leverage the QMS as a competitive advantage for the business.
Through robust Internal auditing & customer feedback analysis, develop new QMS relevant processes, improvement plans & lead efforts to reduce/mitigate any risk to the QMS & service offerings.
Co-ordinate independent external audits of the Service QMS within the respective Global regions. Act on findings and recommendations in a robust manner
Interface with leadership on initiatives to support strategic decision making
Ensure QA support to Global Services business priorities & projects.
Influences product compliance, process development and new product introduction (NPI) including automation software.
Who you are
Bachelor's degree, preferably in a Science or Engineering discipline with 7+ years experience as QA manager
Extensive work experience in Quality Assurance/Quality Engineering within Life Science or Biopharma manufacturing environments
Comprehensive understanding of ISO 9001/13485 and pharma GMP QMS requirements
Excellent communication skills (written and oral)
Demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls, verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management, services)
Experienced in continuous improvement methodologies & tools (i.e. LEAN six sigma, SPC and data trending)
Able to travel globally to perform/support audits as needed.
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
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 global life sciences leader with over 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.
Publiceringsdatum2020-12-21Så ansöker duSista dag att ansöka är 2021-01-20
Klicka på denna länk för att göra din ansökanAdressCytiva Sweden AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cytiva Sweden AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Arbetsplats GE Healthcare Bio-Sciences AB
Jobbnummer 5498576
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