Quality Project Lead

Thermo Fisher Scientific•Cincinnati, OH

11d•Onsite

About The Position

As part of Thermo Fisher Scientific’s Cincinnati site, which specializes in developing and manufacturing oral solid drugs for the Pharma Services Group, the role supports quality systems and compliance across the organization. The work includes investigating quality issues, supporting audits and regulatory inspections, maintaining quality documentation, analyzing quality data, and advancing continuous improvement. The position partners with cross-functional teams to implement effective corrective actions and support compliance with GMP/GxP regulations, ISO standards, and applicable quality system requirements. The site provides drug development and commercial manufacturing services, including controlled and sustained release solid oral dosage forms, osmotic release dosage forms, liquid fill hard capsules, controlled substances manufacturing, and abuse-deterrent dosage forms. The role requires the ability to work in manufacturing environments and comply with PPE requirements as needed. The posting describes the work schedule as standard office hours (40 hours per week) and the environmental conditions as office. Relocation assistance is not available. Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization. Employment is contingent on applicable pre-employment screening, including a background check and drug screening.

Requirements

Advanced degree plus 3 years of relevant experience, or bachelor’s degree plus 5 years of relevant experience.
Quality assurance and/or quality control experience within a regulated industry.
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 and external audits and regulatory inspections.
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 and 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.
Ability to work in manufacturing environments and comply with PPE requirements as needed.

Nice To Haves

Degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field preferred.
Pharmaceutical, medical device, or biotech experience preferred.
Client-facing experience preferred.
Project management experience preferred.

Responsibilities

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.