Senior Director, Danaher Business System Leader - QARA
Danaher Corporation
Summary
The Senior Director, Danaher Business System Leader – QARA is a global role responsible for embedding DBS into how the Quality Assurance & Regulatory Affairs (QARA) organization plans, operates, and continuously improves across Cytiva. Overall, role as a global DBS change leader for QARA, focused on embedding continuous improvement into quality and regulatory processes while strengthening compliance, performance, capability, and digital enablement.
Job description
Further this role will deploy and embed DBS across global QARA, ensuring DBS methods are integrated into the QMS and used to improve quality, regulatory, and operational performance. You will be responsible to lead the integration of DBS within the QMS by ensuring DBS methodologies are appropriately embedded in quality processes and that DBS-driven activities (e.g., Kaizens, PSPs, problem-solving initiatives) trigger the required quality records, risk assessments, and closed-loop actions whenever product, process, or compliance impacts are identified. Partner closely with global QARA leadership, Quality Assurance, Regulatory Affairs, Supplier Quality, Operations, and DBS resources to drive regulatory-compliant execution, risk reduction, and sustained performance improvement through disciplined application of DBS. While you will contribute across the areas below, success is driven first by establishing a strong DBS operating system within QARA, then delivering measurable compliance and performance improvements, and finally scaling capability and digital enablement. This is a full-time, global role reporting into the Group VP QARA -Biotechnology and will be an onsite role in Amersham, UK or Marlborough, MA.
What will you do:
- Lead the development and execution of the QARA DBS roadmap, including Policy Deployment, KPI management, Daily Management, visual management, and structured problem solving.
- Drive an effective operating cadence through leadership reviews, risk assessments, opportunity evaluations, and continuous improvement planning.
- Build DBS capability across the QARA organization through coaching, training, kaizen facilitation, standard work implementation, and disciplined follow-up.
- Advance quality, compliance, and operational excellence by applying DBS tools to address deviations, CAPAs, audit findings, inspections, regulatory commitments, and customer complaints.
- Manage the global QARA kaizen and problem-solving funnel, ensuring initiatives are strategically prioritized, rigorously executed, and sustainably embedded.
- Represent QARA within the DBS Community of Practice, sharing best practices and leveraging enterprise-wide learnings to strengthen organizational performance.
- Champion digital, automation, and AI-enabled solutions that enhance DBS execution, improve KPI visibility, streamline workflows, and accelerate problem solving.
Who you are:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Minimum of 7 years of experience applying DBS, Lean, or continuous improvement methodologies within Quality Assurance, Regulatory Affairs, Supplier Quality, Manufacturing, or other regulated environments.
- Demonstrated ability to lead improvement through influence, partnering across functions, cultures, and leadership levels in a global organization.
- Strong understanding of quality and regulatory processes and the ability to drive improvement while maintaining regulatory and compliance rigor.
- Proven experience driving sustained results through structured problem solving, kaizen leadership, and performance management.
It would be a plus if you also possess:
- DBS, Lean, or Continuous Improvement certification.
- Experience supporting global organizations and driving process harmonization across regions or sites.
- Experience applying digital or AI‑enabled solutions in regulated or compliance‑driven environments.
- Experience partnering with enterprise organizations (e.g., DBSO) and external experts.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Minimum of 7 years of experience applying DBS, Lean, or continuous improvement methodologies within Quality Assurance, Regulatory Affairs, Supplier Quality, Manufacturing, or other regulated environments.
- Demonstrated ability to lead improvement through influence, partnering across functions, cultures, and leadership levels in a global organization.
- Strong understanding of quality and regulatory processes and the ability to drive improvement while maintaining regulatory and compliance rigor.
- Proven experience driving sustained results through structured problem solving, kaizen leadership, and performance management.
- DBS, Lean, or Continuous Improvement certification.
- Experience supporting global organizations and driving process harmonization across regions or sites.
- Experience applying digital or AI‑enabled solutions in regulated or compliance‑driven environments.
- Experience partnering with enterprise organizations (e.g., DBSO) and external experts.
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
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.