New · posted Oct 30
Thermo Fisher Scientific · Pharmaceuticals
Quality Project Lead
- Cincinnati, OH
- On-site
- Full-time
- Senior & Principal
The role
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.
Discover Impactful Work
As a Quality Specialist III, you will help ensure high quality standards across our operations by maintaining regulatory compliance and driving continuous improvement of quality systems. You will partner with cross-functional teams to investigate quality issues, implement corrective actions, and foster a culture of quality excellence in support of our Mission.
What you need
Education
• Advanced degree plus 3 years of relevant experience, or bachelor’s degree plus 5 years of relevant experience
• Degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field preferred
Experience
• Quality assurance and/or quality control experience within a regulated industry; pharmaceutical, medical device, or biotech experience preferred
• Experience with quality management systems, CAPA, deviation management, and change control
• Demonstrated expertise in root cause analysis, investigations, and corrective action implementation
• Experience conducting and hosting internal/external audits and regulatory inspections
• Client-facing experience preferred
• Project management experience preferred
Knowledge, Skills, Abilities
• Strong knowledge of GMP/GxP regulations, ISO 9001/13485, and other relevant quality system requirements
• Proficiency in statistical analysis, data trending, and quality metrics reporting
• Strong technical writing skills for SOPs, investigation reports, and other quality documentation
• Advanced problem-solving skills with strong attention to detail
• Excellent verbal and written communication and strong interpersonal skills
• Ability to work independently and collaborate with or guide cross-functional teams
• Proficiency with quality systems software such as TrackWise and document control systems, as well as Microsoft Office
• Knowledge of risk assessment methodologies and continuous improvement tools
Physical Requirements/Work Environment
• Ability to work in manufacturing environments and comply with PPE requirements as needed
Competencies
• Quality focused
• Collaborative
• Accountable
• Analytical problem solver
• Effective communicator
• Continuous improvement mindset
What you'll do
In this role, you will support quality systems and compliance activities across the organization, applying your technical expertise to investigations, audits, documentation, and continuous improvement initiatives.
• Investigate quality issues using root cause analysis and appropriate investigation techniques
• Manage and support CAPA, deviation, and change control processes
• Conduct and host internal and external audits and support regulatory inspections
• Author and maintain SOPs, investigation reports, and other quality documentation
• Analyze quality data, trends, and metrics to identify opportunities for improvement
• Apply risk assessment methodologies and continuous improvement tools
• Collaborate with and guide cross-functional teams in implementing effective corrective actions
• Support ongoing compliance with GMP/GxP regulations, ISO standards, and applicable quality system requirements
Pay
Thermo Fisher Scientific didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! See our website for more information on Benefits & Total Rewards
Where you'll work
Cincinnati, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Cincinnati, OHWorking conditions
Standard Office Hours (40/wk)
Environmental Conditions
Office
Division/Site Specific Information
The Cincinnati site specializes in making oral solid drugs and developing them for the Pharma Services Group. Thermo Fisher Scientific’s oral solid dose (OSD) site in Cincinnati, Ohio, supported by over 800 employees, offers various drug development and commercial manufacturing services. These services include controlled and sustained release solid oral dosage forms, osmotic release dosage forms (laser drilling), liquid fill hard capsules, controlled substances manufacturing, and abuse-deterrent dosage forms.
Location, Work Authorization & Pre-Employment Requirements
Please review the following requirements before applying:
- Relocation: Relocation assistance is not available for this position.
- Work Authorization: Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization.
- Pre-Employment Screening: Employment is contingent upon successful completion of all applicable pre-employment requirements, including a background check and drug screening, in accordance with company policy and applicable law.
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in Ohio5 roles publishing pay
Senior & Principal roles in the US325 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Ohio (middle half) | $80,000 | $81,000 | $92,500 |
| All US (middle half) | $104,000 | $123,000 | $143,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 988 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk11
- Investigations and CAPA8
- Collaboration and leadership7
- GMP and compliance6
- Documentation and SOPs4
- Lab testing and methods3
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Thermo Fisher on Regulatory Jobs
- 84
- Open roles
- 74
- Distinct roles
- 37
- Locations
By discipline
- Quality77 92%
- Regulatory5 6%
- Compliance & Safety2 2%
By level
- Senior & Principal38 45%
- Associate & Specialist22 26%
- Manager21 25%
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Quality Project Lead at Thermo Fisher
Open until filled.