Danaher Corporation Quality Assurance Compliance Lead in Westborough, Massachusetts
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 QA Compliance Lead to work with our expert Quality Assurance team of employees across the world. Do you have a passion for QA Compliance? Then we would love to hear from you.
What you’ll do
Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. Overall responsibility for QMS and QA projects to ensure compliance with ISO 9001 and Cytiva procedures.
Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Utilizes risk management tools in accordance with documented procedures. Supports risk mitigation activities through the Risk Management process.
Who you are
Bachelor’s degree; or a High School diploma/GED and minimum 6 years work experience in a Quality or Regulatory Assurance related field.
Minimum 3 years’ experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role.
Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
Demonstrated knowledge of Quality Management System tools and ability to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities, corrective and preventive action (CAPA), risk management, and product quality improvement.
Experience with cGMP and governmental regulations related to drug manufacturing.
Ability to read and interpret professional journals and technical procedures.
Basic understanding of materials, properties, manufacturing processes, and product assembly.
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 (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .