Senior Quality Manager (REMOTE)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Title: Senior Quality Manager (REMOTE)

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.

Division/Site Specific Information

You'll be remotely based in Cincinnati, Ohio, Manati, Puerto Rico, or High Point, North Carolina location, where you'll have the opportunity to work in a dynamic environment that fosters innovation and collaboration. You will support our Drug Production Division at Thermo Fisher Scientific and play an important role in our company's success.

Discover Impactful Work:

As a Senior Manager of Quality at Thermo Fisher Scientific, you will play a key leadership role in advancing quality, compliance, and operational excellence across the Oral Solid Dose business unit.

This role is responsible for driving continuous improvement across global sites, leading compliance initiatives, and identifying opportunities to improve efficiency, consistency, and quality system performance.

A Day in the Life:

• You will serve as a critical liaison between global quality functions and site quality leadership, helping to align business unit priorities with site execution. Working closely with Site Quality Heads, operations, technical teams, regulatory, commercial, and client-facing functions, you will support the implementation of global quality strategies, strengthen inspection readiness, and promote a culture of proactive, risk-based quality management.

• In this role, you will also support clients and quality heads for escalations, helping to ensure timely communication, effective issue resolution, and strong customer confidence.

• You will support complex investigations, CAPA effectiveness, quality performance reviews, and cross-site improvement initiatives while leveraging Practical Process Improvement (PPI), data-driven decision-making, and standardized best practices.

• As a member of the broader quality leadership network, you will help drive compliance maturity, share learnings across sites, and enable consistent execution of quality expectations across the global Oral Solid Dose network.

• Your leadership will directly support Thermo Fisher Scientific’s mission to enable our customers to make the world healthier, cleaner, and safer.

Keys to Success:

Education

• BS degree required. Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field

• Advanced degree preferred.

• Professional certifications desired (ASQ, Lean Six Sigma, etc.)

Experience

• Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6-8 years of experience in pharmaceutical, medical device, or regulated life sciences industry required.

• 5 years of quality management/leadership experience required.

• Experience implementing continuous improvement initiatives

• Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis

• Experience hosting regulatory inspections and customer audits

Knowledge, Skills, Abilities

• 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

• 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

• Proficiency with quality management software systems

• Ability to travel up to 50%

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.