GLP QA Lead – Preclinical Translational Research

University of Pennsylvania; Kennett Square (Chester County); On-site; USD 59,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Tuition benefits

Retirement plans

Time away from work

Long-term care insurance

Wellness programs

Professional development

University resources

Discounts and services

Flexible work hours

Home ownership assistance

Adoption assistance

Job summary

The Quality Assurance Officer at University of Pennsylvania oversees GLP compliance for the Preclinical Service Core at New Bolton Center and supports related facilities. You will audit study protocols, review SOPs, and coordinate inspections with FDA and sponsor QA teams.

Onboarding of pre-vet students and GLP training are key parts of the role. You’ll maintain GLP archives and guide staff on regulatory standards while supporting the RDSF facility with GLP program development.

Qualifications

• Experience in a GLP environment with knowledge of GLP required.
• Experience in medical device development and/or gene therapy preferred.
• Demonstrated ability to work collaboratively, multi-task, and meet deadlines in a fast-paced setting.
• Strong analytical skills and attention to detail.
• Experience meeting mission-critical deadlines.
• Proficiency with Microsoft Word, Excel, and Access.

Responsibilities

• Manage Penn’s GLP compliance program for the Preclinical Service Core.
• Perform inspections, audits, and SOP reviews to ensure GLP standards are met.
• Coordinate onboarding of pre-vet students and staff training on GLP.
• Support FDA, sponsor QA, IACUC and USDA inspections.
• Develop and maintain GLP archives and training documentation.
• Collaborate with RDSF to implement GLP programs at related facilities.

Skills

GLP

Medical devices

Collaboration

Analytical skills

Deadlines

MS Office

Education

Bachelor’s degree in life sciences

Master’s degree in Regulatory Affairs or QA certification preferred

Tools

Microsoft Word

Microsoft Excel

MS Access

Job description

The Quality Assurance Officer at University of Pennsylvania oversees GLP compliance for the Preclinical Service Core at New Bolton Center and supports related facilities. You will audit study protocols, review SOPs, and coordinate inspections with FDA and sponsor QA teams.

Onboarding of pre-vet students and GLP training are key parts of the role. You’ll maintain GLP archives and guide staff on regulatory standards while supporting the RDSF facility with GLP program development.