Senior Quality Manager

As Site QA Leader you will collaborate closely with cross functional leadership and associates to ensure compliant execution, monitoring, and continuous improvement of the implemented QMS in line with certification requirements and customer expectations. This position is located in Songdo, Incheon, Korea and will be an onsite position.

This role will report directly into the Global QARA organization.
What you’ll do

• Setup Cytiva QMS for the new plant and obtain ISO certification.
• Support clean room and site qualification (Facilities)
• Represent the Songdo, Incheon site as the Quality Management Representative
• Responsible for the leadership & development of the QA site function.
• Responsible for implementing the Cytiva QMS
• Ensure QMS procedures, work instructions, and IT System effectively support the Songdo site organization - Collaborate with Global QMS Subject Matter Experts (SME) as required.
• Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
• Coach/mentor associates on QMS requirements
• Accountable for setting & monitoring Quality KPI’s including, reporting on performance/ trend insights within business reviews.
• Lead Quality Management reviews
• Ensure effective communication style with stakeholders and establish cross functional operating mechanisms, where appropriate to ensure Quality goals are met.

Who you are

• Minimum, Bachelor's degree, preferably in a Science or Engineering discipline
• A minimum of 7 years working in Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environments
• 2-4 years of supervisory experience
• Quality Assurance/Quality Engineering Senior leadership experience
• Knowledge of ISO, FDA, cGMP’s, and CFR requirements
• Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.
• Knowledge of quality statistical methods and tools
• Experience supporting validation and technology transfer activities.
• Exceptional analytical, problem solving & root-cause analysis skills.
• Ability to manage budgets
• Excellent communication skills (written and oral)
• Experienced in managing teams and working cross – functionally, both locally & globally.
• Demonstrated expertise to effectively communicate within all levels of the organization around validation, production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.