Quality Management System Manager

Job TitleQuality Management System Manager

Job Description

Key areas of responsibilities

• Plan, generate, and coordinate for KGMP
• Ensures compliant and effective QMS’s are maintained in scope.
• Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure.
• Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
• Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.
• Ensures Q&R requirements are effective in all processes in scope
• Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.

Key performance indicators

• Timely completion of KGMP
• QMS non- conformities and CAPA/Non-conformity resolution
• New QMS functionality deployed on time and within budget constraints
• Current system functionality deployed across a large user group leveraging compliance capabilities and improved efficiency.
• Leadership and team performance indicators
• Recognition by business leadership as key resource to the business

Qualifications & Requirements

• Minimum of three years of similar work experience
• Experience working in disciplined regulated industry and in applying automated technology
• Experience with business application implementation projects including experience as an active contributor on projects with scheduled deliverables
• Familiar with process management methodologies and practices
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as Korea MD regulation, KGMP, ISO 13485, ISO 9001, and FDA QSR
• Effective written and verbal communication skills in English & Korean languages

Why should you join Philips?Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.