Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP)
Safety Standards, Cleanroom:
no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed 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 Quality Systems Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services. This role offers the opportunity to make a meaningful impact by protecting patient safety, supporting innovative research, and enabling critical scientific discoveries.
Location:
Middletown, VA Relocation assistance is NOT provided.
REQUIREMENTS
Education & Experience Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in quality experience in pharmaceutical, medical device or regulated industry preferred
Preferred Fields of Study:
Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field 3-5 years of team leadership experience preferred Technical & Regulatory Expertise Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP) Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis) Experience leading internal/external audits and regulatory inspections Demonstrated ability to develop and mentor quality teams Successful experience implementing and improving quality systems Skill in cross-functional collaboration and stakeholder management Strong analytical and problem-solving capabilities Clear written and verbal communication skills Proficiency with quality management software (TrackWise, Document Control Systems) Experience with continuous improvement methodologies (Lean, Six Sigma) Ability to promote quality culture across all levels Focus on customer needs and ability to manage customer/supplier relationships Project management experience preferred Additional Requirements Ability to travel up to 25% as needed Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
