Role Overview
Senior Quality Operations Leader, Equipment Services. The role partners internally and globally to manage a world‑class Quality Assurance program, meeting key customer expectations and enhancing growth in the Equipment Services business. The position reports to the Sr Manager, Equipment Services Quality and is part of the Hardware Solutions Quality Assurance and Regulatory Affairs organization. This role can be located at any Cytiva or Danaher location or be fully remote.
Key Responsibilities
- Monitor Quality KPIs and ensure compliance with quality standards through collaboration with the Global Quality Team and Equipment Services.
- Lead the Equipment Services Internal Audits program, including planning and execution of internal audits.
- Support the Deviations and Complaints processes, participating in root cause analysis and developing corrective action plans.
- Lead monthly CAPA/Change Control review boards, weekly quality reviews, and daily visual management activities.
- Collaborate cross‑functionally to standardize processes globally and drive continuous improvement initiatives.
Required Qualifications
- Bachelor’s degree and a minimum of 5+ years of experience in a Quality or Regulatory Assurance related field (including Biopharma or Life Sciences).
- Qualified Auditor to ISO9001.
- Demonstrated experience with data analysis, custom report creation, and standardizing reporting across multiple organizations.
- Ability to identify, prioritize, and solve problems using DBS tools.
- Strong interpersonal skills and the ability to communicate complex information effectively (written and oral).
- Proficiency with MS Office suite (word processing, spreadsheet, presentation, database applications).
Preferred Qualifications
- Experience with continuous improvement activities.
- Qualified Auditor to ISO13485.
