GLP Compliance Lead, Microbiology Lab

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

Job summary

Mykelly is seeking a GLP Compliance Manager responsible for building and sustaining the GLP framework within a startup lab. The role requires establishing SOPs, training, data integrity, and records control to enable compliant GLP studies.

The successful candidate will lead audits and readiness activities, align with EPA and FDA guidelines, and guide the study director function as needed to ensure robust, compliant microbiology testing operations.

Qualifications

• BS in Microbiology, Biology or related life science; MS/PhD preferred.
• 7+ years in a regulated microbiology lab with 3+ years directing GLP studies.
• Strong knowledge of 21 CFR Part 58, 40 CFR Part 160, and OECD GLP.
• Experience implementing GLP systems in startup or new-lab settings.

Responsibilities

• Design, implement and sustain the GLP compliance framework for a new microbiology testing operation.
• Develop and execute a phased readiness roadmap with milestones.
• Write and implement SOPs, training matrix and document control system; maintain master schedule.
• Establish data-integrity controls and manage validation of electronic record systems.
• Set up records archive with indexing, retention and access procedures.
• Define equipment controls for calibration, maintenance and qualification; ensure BSL-2 conditions.
• Oversee test article handling: receipt, chain of custody, storage and retention.
• Lead readiness for sponsor audits and regulatory inspections, including CAPA and responses.
• Direct GLP microbiology studies as Study Director when designated; approve protocols and amendments.

Skills

GLP compliance

Regulatory knowledge

SOP development

Training & coaching

Documentation control

Audit readiness

Project management

Microbiology knowledge

Lab operations

Data integrity

Education

BS in Microbiology or related life science

MS or PhD preferred

Tools

LIMS

Electronic records

Job description

Mykelly is seeking a GLP Compliance Manager responsible for building and sustaining the GLP framework within a startup lab. The role requires establishing SOPs, training, data integrity, and records control to enable compliant GLP studies.

The successful candidate will lead audits and readiness activities, align with EPA and FDA guidelines, and guide the study director function as needed to ensure robust, compliant microbiology testing operations.