Sr Quality Systems Manager

Work Schedule

Environmental Conditions

Job Description

The role can sit fully onsite at any of our SUD locations including: Logan, UT, Millersburg, PA, Lebanon, TN, Cramlington, UK and Singapore.

Unique Opportunity

Become the Sr Manager of Quality Systems at Thermo Fisher Scientific and contribute to our mission of enabling our customers to make the world healthier, cleaner and safer!

Lead quality initiatives throughout our Single Use Division and influence the development of Single Use Technology solutions to global Bio-Pharmaceutical and Biotech industry challenges. Ensure our products meet high standards and encourage a culture of quality throughout the organization.

Job Responsibilities

• Develop and oversee the implementation of a comprehensive Quality strategy for the Single Use Division, ensuring compliance with applicable regulatory requirements, Corporate Policies, and customer agreements, and delivering a consistent supply of quality products
• Establish, monitor, and take action to measure Quality Management System (QMS) performance against quality objectives and drive progress. Collaborate intensively with engineering and operations teams to drive continuous improvement in the effectiveness and efficiency of quality systems processes, ensuring sustained compliance and safety while reducing the Cost of Poor Quality. Optimize and implement supplier qualification and maintenance processes, and partner with suppliers to address supplier performance-related matters impacting QMS performance.
• Serve as a role model leader, aligning with the Thermo Fisher Code of Conduct and embodying our 4-i Values and Practical Process Improvement methodology in all actions. Attract, lead and mentor a high-performing team, fostering a culture of excellence and continuous improvement.
• Support the commercial organization and lead Quality-related commercial discussions with customers. Communicate and address material claims and issues promptly in collaboration with Risk Management and Legal.
• Perform all job duties in a safe manner, adhering to all safety policies and procedures.

Education

• Bachelor’s Degree or Higher required

Experience

• 8 Years of Quality Experience within the Medical Device or Pharmaceutical Industry, supporting regulated products.
• Minimum of 5 years in leadership/management in GxP compliance environments, preferably FDA regulated.

Knowledge, Skills, Abilities

• Demonstrates Company 4-i Values - Integrity, Intensity, Innovation, Involvement - in the execution of all responsibilities.
• Ability to think critically and overcome business hurdles with a proactive and problem-solving approach.
• Proven success in attracting, recruiting, developing, and retaining high-potential talent, and working effectively in a diverse, matrixed environment. Strong credibility and ability to cultivate positive professional relationships with subordinates, peers, leaders, and external collaborators.
• Exceptional written and verbal communication skills for effective engagement across all organizational levels.
• Strong history of involvement with design controls and new product development.