Danaher Corporation Quality Assurance Lead - Change Control in Westborough, Massachusetts
Cytiva is a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare Life Sciences, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020. Our customers undertake life-saving activities ranging 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 they need to work better, faster and safer, leading to better patient outcomes.
Whether you’re a biochemist, a finance guru or manufacturing professional, 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 is your place to further your career.
Cytiva is a $3 billion (USD) global life sciences leader, with over 6,500 associates across 41 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.
As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.
We are looking for a QA Compliance Lead – Change Control to work with our expert Quality Assurance 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 change control program 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.
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Equal Opportunity Employer
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 at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail email@example.com to request accommodation.
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) .