Lonza
Overview
Join to apply for the
Manager, Quality Management Systems
role at
Lonza
in Houston, United States (Texas). Lonza is a global leader in life sciences operating across five continents. Our greatest scientific solution is talented people working together to devise ideas that help businesses and people. We support our people in owning their careers and encourage ideas big and small that can improve the world. Key Responsibilities
Manages and oversees the change control, deviation, CAPA and effectiveness check systems. Supports and trains site subject matter experts (SMEs) in how to execute change control, deviation, CAPA and effectiveness checks. Manages a team responsible for coordinating the site’s change control, deviation, CAPA and effectiveness check programs. Acts as a SME in how to execute compliant change control, deviation, CAPA and effectiveness checks. Supports the coordination and execution of complex change controls requiring sitewide implementation. Provide QMS leadership during eQMS development/improvement programs and/or projects involving department, cross-functional, and global teams. Functions as a TrackWise SME related to the change control, deviation, CAPA and effectiveness check modules. Supports and trains QMS Team hosts of change controls review board, deviation review board and CAPA review board. Acts as SME related to the change control, deviation, CAPA and effectiveness check systems in customer and Health authority inspections. Provides KPIs for change control, deviation, CAPA and effectiveness check systems. Key Requirements
Bachelor's in Life Sciences, Engineering, Quality Management or related science discipline. 5+ years in a cGMP environment and related QA field. Experience with Health Authority Regulations (US FDA, EMA, MHRA, etc.). Experience in a commercial pharmaceutical manufacturing environment. Experience in aseptic manufacturing environment. Certified Quality Auditor desired. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, or protected veteran status. Reference: R70844 Apply
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Join to apply for the
Manager, Quality Management Systems
role at
Lonza
in Houston, United States (Texas). Lonza is a global leader in life sciences operating across five continents. Our greatest scientific solution is talented people working together to devise ideas that help businesses and people. We support our people in owning their careers and encourage ideas big and small that can improve the world. Key Responsibilities
Manages and oversees the change control, deviation, CAPA and effectiveness check systems. Supports and trains site subject matter experts (SMEs) in how to execute change control, deviation, CAPA and effectiveness checks. Manages a team responsible for coordinating the site’s change control, deviation, CAPA and effectiveness check programs. Acts as a SME in how to execute compliant change control, deviation, CAPA and effectiveness checks. Supports the coordination and execution of complex change controls requiring sitewide implementation. Provide QMS leadership during eQMS development/improvement programs and/or projects involving department, cross-functional, and global teams. Functions as a TrackWise SME related to the change control, deviation, CAPA and effectiveness check modules. Supports and trains QMS Team hosts of change controls review board, deviation review board and CAPA review board. Acts as SME related to the change control, deviation, CAPA and effectiveness check systems in customer and Health authority inspections. Provides KPIs for change control, deviation, CAPA and effectiveness check systems. Key Requirements
Bachelor's in Life Sciences, Engineering, Quality Management or related science discipline. 5+ years in a cGMP environment and related QA field. Experience with Health Authority Regulations (US FDA, EMA, MHRA, etc.). Experience in a commercial pharmaceutical manufacturing environment. Experience in aseptic manufacturing environment. Certified Quality Auditor desired. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, or protected veteran status. Reference: R70844 Apply
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