Manager, Quality Management Systems

Lonza • Houston, TX

76d

About The Position

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

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 commercial pharmaceutical manufacturing environment.
• Experience in aseptic manufacturing environment.
• Certified Quality Auditor desired.

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 of individuals 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.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees