Sr. Manager, Quality

Regulatory Jobs; Oakwood (OH); On-site; USD 140,000 - 190,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Manager of Quality to drive strategic quality initiatives and support a culture of continuous improvement. You will oversee quality management systems, ensure regulatory compliance, and enhance customer experience through stringent quality standards.

You will manage QA/QC teams, build partnerships with operations, R&D, and commercial groups, and lead investigations using PPI and risk-based approaches to maintain inspection readiness and

Qualifications

• Advanced degree plus 6+ years in pharma, medical device, or regulated life sciences.
• 5+ years of quality leadership experience.
• Expert knowledge of ISO 9001:2015 and ISO 17025.
• Experience hosting regulatory inspections and customer audits.

Responsibilities

• Lead strategic quality initiatives and continuous improvement.
• Oversee QMS, regulatory compliance, CAPA and change control processes.
• Develop site leadership and partnerships with operations, R&D, and customers.

Skills

Quality leadership

Cross-functional leadership

ISO quality standards

CAPA investigations

Risk analysis

Education

Advanced degree

Bachelor's degree

Tools

QMS software

FMEA

Root cause analysis

Job description

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:

As a Senior Manager of Quality at Thermo Fisher Scientific, you will guide strategic quality initiatives and support a culture of continuous improvement across our organization. You'll oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards. Working closely with cross-functional teams, you'll develop and implement quality strategies that support our mission of enabling customers to make the world healthier, cleaner, and safer.

In this role, you'll manage quality assurance and quality control teams while building strong partnerships with operations, R&D, commercial teams, and customers. You'll guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches. Your leadership will be essential in maintaining inspection readiness, managing customer relationships, and ensuring compliance with global regulatory requirements.

As a member of the site leadership team, you'll support quality initiatives that deliver consistent product excellence while meeting business objectives. You'll develop quality professionals, lead investigations, and implement data-driven solutions that enhance our quality systems and customer satisfaction.

REQUIREMENTS:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical, medical device, or regulated life sciences industry
• Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field
• Professional certifications desired (ASQ, Lean Six Sigma, etc.)
• 5+ years of quality management/leadership experience
• Expert knowledge of global quality standards (ISO 9001:2015 and ISO 17025)
• Strong understanding of quality management systems and GMP requirements
• Demonstrated experience leading quality investigations, CAPA, and change control processes
• Experience implementing continuous improvement initiatives
• Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
• Excellent project management and cross-functional leadership abilities
• Strong data analysis and problem-solving capabilities
• Excellent written and verbal communication skills
• Ability to build collaborative relationships at all levels
• Experience hosting regulatory inspections and customer audits
• Proficiency with quality management software systems
• Ability to travel up to 10%