Sr. Manager, Quality

RXinsider LTD.; Oakwood, Northern (OH, KY); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Thermo Fisher Scientific seeks a Senior Manager of Quality to guide strategic quality initiatives and support continuous improvement across the organization. You will oversee quality management systems, ensure regulatory compliance, and enhance customer experience with robust quality standards.

You’ll manage QA/QC teams, partner with operations, R&D, and commercial teams to implement PPI-based improvements and risk-based approaches.

Qualifications

• 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: 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 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
• Strong understanding of quality management systems and GMP requirements
• 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 25%

Responsibilities

• Lead strategic quality initiatives and support a culture of continuous improvement
• Oversee quality management systems, regulatory compliance and customer satisfaction
• Guide investigations, CAPA, and change control processes
• Develop and implement quality strategies with cross-functional teams (Operations, R&D, Commercial)
• Maintain inspection readiness and manage regulatory inspections and customer audits
• Lead quality professionals, mentor site leadership, and drive data-driven improvements

Skills

Leadership

Cross-functional teamwork

Project management

Data analysis

Communication

Problem solving

Regulatory knowledge

Audits and inspections

Continuous improvement

Travel readiness

Education

Advanced degree or Bachelor's with 8+ years of experience (pharma/med device/regulatory life sciences)

Tools

Quality management software

FMEA

Risk Analysis

Root Cause Analysis

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
• 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 25%