Manager, QMS

Work Schedule
First Shift (Days)

Environmental Conditions
Office

Job Description

The QMS Manager will lead the Quality Management Systems team at Thermo Fisher Scientific Inc., ensuring compliance with FDA, EMA, and other cGMP regulations. This role offers the opportunity to work in an exceptionally dynamic environment, driving world-class quality standards.

What will you do?

• Coordinate, manage, and ensure the successful day-to-day operations of the QMS team.
• Manage change management program, including planning, execution, oversight, and governance.
• Manage CAPA program, including planning, execution, oversight, and governance.
• Review and approve department standard operating procedures.
• Coordinate daily activities to ensure quality, commitment to schedules, and maintain output.
• Provide support for site safety initiatives.
• Perform tasks as requested by Senior Management to support Quality oversight activities.
• Represent the company at regulatory inspections, respond to questions, and support corrective actions as appropriate.
• Set objectives and tasks for staff, regularly reviewing their progress.
• Communicate effectively with peers, Manufacturing, Process Development, Procurement, and Quality Control staff to resolve technical issues and direct activities.

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• Bachelor's Degree or equivalent experience in Life Sciences, Biotechnology, Engineering, or related field.

• 8+ years of experience within a GMP Environment.
• 5+ years of experience within Quality Assurance or Quality Compliance preferred.
• 3+ years in a leadership role is preferred.

• Ability to drive functional, technical, and operational excellence.
• In-depth knowledge of FDA, EMA, and other applicable regulatory requirements.
• In-depth knowledge of critical QMS elements.
• Proficient with computer (MS Office), and internet skills.
• Excels in cross-functional team environments.
• Well organized and able to work independently with minimal supervision.
• Skilled in risk management application.
• Demonstrated dedication to principles of Integrity, Respect, and Excellence.
• Knowledge of pre-license / pre-approval inspection readiness and regulatory submissions is preferred.
• Experience with regulatory inspections.
• Excellent interpersonal skills and the ability to build and maintain relationships.
• Proven leadership skills with the ability to influence others and lead significant change.
• Strong communication and presentation skills, both written and verbal.