Quality Systems Manager

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 Bachelors 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 Stateswithoutsponsorship.
• Must be able to pass a comprehensive background check whichincludes a drug screening.