GLP Compliance Architect for Startup Microbiology Lab

Kelly Science, Engineering, Technology & Telecom; Exton (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom seeks a GLP Compliance Lead to design and implement a full GLP framework for a new microbiology testing operation in Exton, PA. This is an individual-contributor leadership role to build the foundation, SOPs, and data-control systems while ensuring regulatory alignment.

You will lead readiness for sponsor audits, establish an independent QA unit, and collaborate on CAPA responses, reports, and regulatory inspections as the program matures.

Qualifications

• BS in Microbiology, Biology or related life science; MS or PhD preferred.
• 7+ years in a regulated microbiology laboratory, including 3+ years managing or directing GLP studies.
• Experience implementing, remediating or maintaining GLP systems, ideally in a start-up or new-lab setting.
• Working knowledge of 21 CFR Part 58, 40 CFR Part 160 and OECD GLP Principles.
• Strong microbiology fundamentals: culture, enumeration, neutralization and root-cause investigation.
• Experience with EPA disinfectant or antimicrobial efficacy studies (AOAC, ASTM) preferred; FIFRA exposure a plus.
• Familiarity with validation of electronic systems (such as LIMS) is a plus.
• Excellent technical writing and ability to work independently with minimal oversight.

Responsibilities

• GLP program build-out
• Write and implement the SOP suite, training matrix and document control system. Maintain the master schedule.
• Establish data-integrity (ALCOA+) controls and manage validation and access controls for computerized and electronic record systems.
• Set up the records archive, including indexing, retention and access procedures.
• Define and implement controls for equipment calibration, maintenance and qualification; ensure BSL-2 conditions support GLP requirements.
• Lead readiness for sponsor audits and regulatory inspections, including mock inspections; manage CAPA and audit responses.
• Direct GLP microbiology studies as Study Director when designated, approve protocols and amendments, manage deviations, timelines and resources.
• Advise on EPA antimicrobial efficacy testing (OCSPP 810 series) and on AOAC and ASTM methods, stay aligned with EPA guidance.
• Train analysts on GLP practices and build a culture of compliance in a start-up environment.

Job description

Kelly Science, Engineering, Technology & Telecom seeks a GLP Compliance Lead to design and implement a full GLP framework for a new microbiology testing operation in Exton, PA. This is an individual-contributor leadership role to build the foundation, SOPs, and data-control systems while ensuring regulatory alignment.

You will lead readiness for sponsor audits, establish an independent QA unit, and collaborate on CAPA responses, reports, and regulatory inspections as the program matures.