Thermo Fisher Scientific · 17 hours ago
Quality Project Lead
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
3+ years expThermo Fisher Scientific is a company that provides comprehensive drug development and commercial manufacturing services. In this role, you will help ensure the highest quality standards across operations, supporting the mission to enable customers to make the world healthier, cleaner, and safer.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Maintain quality systems in compliance with cGMPs, GxP regulations, ISO standards, global regulatory requirements, and company policies
Lead and support investigations related to deviations, nonconformances, and quality events using sound root cause analysis techniques
Manage and support CAPA, change control, and risk assessment activities
Author, review, and approve SOPs, investigation reports, and quality documentation
Conduct and host internal audits, external audits, and regulatory inspections
Analyze quality data, perform trending, and report quality metrics to support continuous improvement
Collaborate with cross-functional teams to implement corrective and preventive actions
Foster a culture of quality excellence and continuous improvement across the organization
Qualification
Required
Advanced Degree with a minimum of 3 years of experience OR Bachelor's Degree with a minimum of 5 years of experience
Preferred fields of study: Life Sciences, Engineering, Chemistry, Biology, or related technical discipline
Experience in quality assurance or quality control within regulated industries (pharmaceutical, biotech, or medical device preferred)
Proven experience with CAPA, deviation management, change control, and quality management systems
Experience conducting and hosting internal and external audits and regulatory inspections
Strong knowledge of GMP/GxP regulations and ISO standards (9001/13485)
Understanding of risk assessment methodologies and continuous improvement tools
Proficiency with quality systems software (e.g., TrackWise, document control systems)
Strong technical writing skills for SOPs, investigations, and quality reports
Proficiency in statistical analysis, data trending, and quality metrics reporting
Strong verbal and written communication skills
Advanced problem-solving and root cause analysis capabilities
Ability to work independently and guide cross-functional teams
Strong interpersonal skills with the ability to collaborate across functions and levels
High attention to detail and commitment to quality excellence
Ability to work in a pharmaceutical manufacturing environment
Ability to wear appropriate personal protective equipment (PPE) as required
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, including a drug screening
Preferred
Project management experience preferred
Benefits
Medical, Dental, and Vision Insurance
Paid Time Off and Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
Company data provided by crunchbase