Quality Manager, CAPA and QMS systems

Danaher Corporation ,
Little Chalfont, Buckinghamshire
More Details

Overview

Job Description

CAPA and qms system manager Amersham, Uppsala or Marlborough 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 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 3.5 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 ar

People also viewed