GLP Compliance Architect - Microbiology Lab

Kelly Services; Exton (PA); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Life insurance

Disability insurance

Retirement savings plan

Holiday pay plans

Transit spending account

Paid sick leave

Job summary

Kelly Services in Exton, PA is seeking a GLP Compliance Manager to found and own the GLP program, designing the framework and leading the setup of a new microbiology testing operation.

You will write SOPs, implement data integrity controls, manage records, calibrations, training, and lead readiness for sponsor audits and regulatory inspections. This is an individual contributor leadership role with no direct reports, reporting to the Quality/Regulatory team.

Qualifications

• 7+ years in a regulated microbiology lab with GLP exposure.
• BS in Microbiology; MS/PhD preferred.
• Experience implementing GLP systems in startup or new-lab settings.
• Knowledge of 21 CFR Part 58, EPA Part 160 and OECD GLP.
• Excellent technical writing; independence in work.

Responsibilities

• Design and implement the GLP compliance framework.
• Build SOPs, training matrix and document control system.
• Establish data-integrity controls and archiving process.
• Set up equipment calibration and BSL-2 labs readiness.
• Lead GLP study management and audits readiness.
• Train analysts in GLP practices and foster compliance culture.
• Coordinate with Quality Assurance and sponsor audits.
• Oversee records, archives and access controls.

Skills

GLP program development

Regulated microbiology lab

SOPs & docs

Data integrity (ALCOA+)

Audit & inspection readiness

Training & mentoring

Education

BS in Microbiology or related life science

MS or PhD preferred

Tools

LIMS

Regulatory guidelines (21 CFR 58, EPA 160)

Job description

Kelly Services in Exton, PA is seeking a GLP Compliance Manager to found and own the GLP program, designing the framework and leading the setup of a new microbiology testing operation.

You will write SOPs, implement data integrity controls, manage records, calibrations, training, and lead readiness for sponsor audits and regulatory inspections. This is an individual contributor leadership role with no direct reports, reporting to the Quality/Regulatory team.