Sr. Quality Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
At Thermo Fisher Scientific, you'll guide Quality Assurance initiatives that make a meaningful impact on global health. As a Senior QA Manager, you'll ensure regulatory compliance, drive continuous improvement, and uphold the highest quality standards across manufacturing operations. Working collaboratively with cross-functional teams, you'll provide strategic direction for quality systems while fostering a culture of excellence. You'll apply your expertise to protect product quality, enhance customer satisfaction, and enable our mission of making the world healthier, cleaner and safer.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device quality systems with minimum 5 years in leadership role
• Preferred Fields of Study: Life sciences, engineering, chemistry, or related technical field
• Advanced certifications (ASQ, Six Sigma, etc.) desirable
• Comprehensive knowledge of cGMP, ISO standards (9001/13485), and global regulatory requirements (FDA, EMA, WHO)
• Experience leading and developing quality teams
• Experience managing quality systems including CAPA, change control, deviations, complaints, and document control
• Strong understanding of risk management methodologies and quality tools
• Experience managing regulatory inspections and customer audits
• Proficiency in root cause analysis and implementation of corrective actions
• Expertise in validation, qualification, and computer system compliance
• Strong written and verbal communication skills
• Ability to collaborate effectively across all organizational levels
• Experience with quality management software systems
• Strong project management and problem-solving capabilities
• Travel up to 20% as required
• Experience implementing continuous improvement initiatives
• Multilingual abilities highly valued for international sites