GLP Compliance Manager

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

GLP Compliance Manager

Exton PA, Direct Hire. Salary: $100,000-$125,000/year

Overview

A growing, science-driven manufacturer of contamination-control products for pharmaceutical and biotech customers is building its first formal GLP testing function. The company currently runs internal testing. This hire will found the GLP department and own its compliance foundation.

Position summary

You will design, implement and sustain the GLP compliance framework for a new microbiology testing operation. You are the subject‑matter expert, with no senior GLP lead onsite. You will build the systems, train the team, and direct GLP studies once the foundation is in place. This is an individual‑contributor leadership role with no direct reports.

What you'll do

• GLP program build‑out
• Perform a gap assessment against FDA 21 CFR Part 58 and EPA 40 CFR Part 160. Develop and execute a phased readiness roadmap with defined milestones.
• Write and implement the SOP suite, training matrix and document control system. Maintain the master schedule.
• Establish data‑integrity (ALCOA+) controls and manage the validation and access controls for computerized and electronic record systems.
• Set up the records archive, including indexing, retention and access procedures.
• Facility, equipment and materials: Define and implement controls for equipment calibration, maintenance and qualification. Ensure laboratory and BSL-2 conditions support GLP requirements.
• Establish test and control article handling: receipt, chain of custody, characterization, storage and retention.
• Establish test system and reagent controls, including organism sourcing and maintenance, media and reagent qualification, and neutralization confirmation.
• Quality oversight and inspection readiness: Work with management to establish an independent Quality Assurance Unit and an inspection program, and collaborate with it once in place.
• Lead readiness for sponsor audits and regulatory inspections, including mock inspections. Manage CAPA and audit responses.
• Evaluate and, where the business chooses, initiate any applicable accreditation or recognition pathway.
• Study management (once the foundation is in place): Direct GLP microbiology studies as Study Director when designated. Approve protocols and amendments, and manage deviations, timelines and resources.
• Advise on EPA antimicrobial efficacy testing (OCSPP 810 series) and on AOAC and ASTM methods, and keep the program aligned with current EPA guidance.
• Training and culture: Train analysts on GLP practices and assess their competency.
• Build a culture of compliance in a start‑up environment.

12-month success measures

• Gap assessment complete and roadmap approved.
• Core SOPs, training records, equipment and archive systems in place.
• Successful mock inspection or internal audit.
• First compliant GLP study initiated.

What we're looking for

• BS in Microbiology, Biology or a related life science. An MS or PhD is preferred.
• 7+ years in a regulated microbiology laboratory, including 3+ years managing or directing GLP studies.
• Demonstrated 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) is strongly preferred. Exposure to FIFRA registration is a plus.
• Familiarity with validation of electronic systems (such as LIMS) is a plus.
• Excellent technical writing and the ability to work independently with minimal oversight.