Thermo Fisher Scientific

Quality Systems Manager

Thermo Fisher Scientific$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Advanced or Bachelor's degree in relevant scientific/technical field plus extensive quality experience in regulated industries
  • Preferred experience includes 6+ years in quality roles within pharmaceutical or medical device sectors
  • 3-5 years of leadership experience preferred
  • Strong background in quality management systems and regulatory requirements (ISO 9001, ISO 13485, FDA QSR/cGMP)
  • Expertise in quality methodologies and tools such as CAPA and FMEA
  • Proficient in quality management software applications
  • Demonstrated experience in cross-functional collaboration and stakeholder management

Responsibilities

  • Guide and enhance quality initiatives across the organization
  • Support continuous improvement and compliance culture
  • Ensure adherence to regulatory requirements and quality standards
  • Lead internal and external audits and inspections
  • Develop and mentor quality teams to excel in their roles
  • Collaborate with various functions to support quality-related projects
  • Analyze quality issues and drive solutions

Benefits

  • Opportunity to make a meaningful impact in healthcare and scientific research
  • Collaborative work environment focused on operational excellence
  • Company commitment to safety and compliance standards
  • Access to professional development and training programs
  • Engagement in innovative projects that drive industry advancements
Full 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

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.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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