Quality Systems Manager

Thermo Fisher Scientific Inc

Middletown, VA

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JOB DETAILS

SKILLS

Analysis Skills, Background Investigation, Biology, Biotech and Pharmaceutical, Cancer, Chemistry, Cleanroom, Communication Skills, Continuous Improvement, Control Systems, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Relationship Management (CRM), Document Control, External Audit, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), ISO 9001, Internal Audit, Leadership, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Medical Equipment, Mentoring, Patient Safety, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Root Cause Analysis, Safety Standards, Supplier Relationship Management (SRM), Systems Administration/Management, Team Lead/Manager, Track Customer Issues, User Documentation, Vendor/Supplier Relations, Willing to Travel, Writing Skills

LOCATION

Middletown, VA

POSTED

14 days ago

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.

About the Company

Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE

10,000 employees or more

INDUSTRY

All

WEBSITE

https://corporate.thermofisher.com/en/home.html