Danaher Corporation QA OPERATIONS LEADER – GLOBAL SERVICES AMERSHAM, in Little Chalfont, United Kingdom
QA OPERATIONS LEADER – GLOBAL SERVICESAMERSHAM,
Help us improve access to life-changing therapies that can transform human healthWe 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 Quality Assurance (QA) Professional to lead the monitoring of the Quality management System (QMS) supporting the Cytiva Global Services organisation. This role will be responsible for leading the trending & reporting on the performance of the QMS during operations reviews, including support with driving continuous improvement initiatives. He/she will collaborate closely with Global Service operations & the Global QA leadership team to ensure timely responses to Customer Feedback. This role will report directly to the Global Services QA Director.
Do you have a passion for Quality Assurance and working with Global teams? Then we would love to hear from you. What you’ll do• Responsible for monitoring Quality KPI’s & reporting performance/ trends insights within business reviews.• Chair regular CAPA board forums to address actions arising from continuous improvement activities & customer feedback/audits.• Chair X-functional complaint handling meetings to drive timely customer feedback responses • Ensure QMS procedures, work instructions, and IT System effectively support the Cytiva Global Services organization - Collaborate with Global QMS systems, documentation control and training leaders as required. • Coach/mentor Global Service associates on QMS requirements• Ensure effective communication style with stakeholders and establish cross functional operating mechanisms where appropriate. • Support ad-hoc assignment based on business needs, including domestic and/or international travel requests
Who you are• Bachelor's degree, preferably in a Science or Engineering discipline with 7 years plus experience • A minimum of 5 years working in Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environments• Quality Assurance/Quality Engineering leadership experience in a GMP environment desired• Comprehensive understanding of ISO 9001 & ISO 13485 requirements • 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• 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) • Ability to multi-task & handle tasks with competing priorities effectively, as well as exercising collaboration, negotiation & conflict resolution skills• Excellent organizational, presentation, meeting facilitation and technical writing skills• Experienced in continuous improvement methodologies & tools (i.e. LEAN six sigma, SPC and data trending)• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Who we areWhatever 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 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. 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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .