[Cytiva Korea] Senior Quality Manager

​​​​​Be part of something altogether life-changing! 

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

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.

In this role, you will have the opportunity to: 

• 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.

1. It would be a plus if you also possess previous experience in:
   

   • 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.