Manager Quality Assurance, Validation

Quality Assurance Manager, Validations

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

This position will manage professional associates and operation support assigned to the Quality Assurance line support and validation team management, equipment program management, Design Change teams responsible for cost savings and supply continuity, including 7+ direct reports, instilling and sustaining a culture of Quality across the teams.

This role also includes the following opportunity to:

• Develop objectives, measures progress against goals, and complete performance reviews for direct reports. Responsible for the performance and results of the teams.
• Adapt departmental plans and priorities to address resource and operational challenges, working cross functionally with other managers to align site objectives, as needed.
• Create an environment that attracts, develops, and retains high quality associates. Champion employee engagement, diversity, professional development and high levels of employee satisfaction.
• Use policies, procedures and business/department plan to guide decisions and problem solving.

The essential requirements of the job include:

• Bachelor's degree with 9+ years of experience or Master's degree with 7+ years of experience. (Degree preferably in Chemistry, Biology, or similar scientific field)
• Previous management/supervisory or project management or leadership experience.
• Requires in-depth understanding of concepts, theories and principles within Quality Systems, Process Validation, Test method validation and Manufacturing Quality disciplines and basic knowledge of other disciplines.
• Experience with non-product software validation for manufacturing automation
• Manufacturing process validation experience - medical device or pharmacy industry highly preferred
• Experience with Quality System Regulation 21 CFR 820, Quality Management System ISO 13485:2016 and ISO 9001:2015

This experience is a plus:

• Experience with equipment lifecycle management
• Lead Auditor Certification

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.