Sr Quality Compliance Associate
Danaher Corporation
Summary
The Sr. Quality Compliance Associate - Quality Systems leads complex quality system activities, provides advanced quality oversight, and drives continuous improvement across the site. This role serves as a subject matter expert who partners across functions to assess quality risks, resolve complex compliance issues, improve quality system performance, and strengthen regulatory readiness.
Job description
In this role, you will have the opportunity to:
- Lead the review and approval of highly complex deviations, corrective and preventive actions (CAPAs), change controls, and other quality system records to ensure compliance with applicable regulations and internal requirements.
- Mentor and train quality system owners, reviewers, and cross-functional stakeholders while serving as a subject matter expert for quality system requirements and best practices.
- Analyze quality system performance metrics, identify adverse trends, recommend corrective actions, and escalate significant compliance risks to Quality Management.
- Lead continuous improvement initiatives that enhance quality system effectiveness, inspection readiness, and site-wide compliance performance.
- Partner with operational, technical, and quality stakeholders on strategic projects, audits, client interactions, and regulatory inspections.
Requirements
- Bachelor's degree in biology, microbiology, chemistry, another life science field, or a related discipline.
- 4 or more years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, medical device, or related industry.
- Advanced experience managing and reviewing quality system records, including deviations, CAPAs, and change controls.
- Experience leading cross-functional investigations, risk assessments, or compliance initiatives.
- Demonstrated experience analyzing quality metrics and driving continuous improvement activities.
- Biologics, cell and gene therapy, or pharmaceutical manufacturing environments (preferred).
- ASQ or RAPS certification (preferred).
Benefits
- Health care program
- Paid time off
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.