GLP Compliance Manager

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

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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Kelly Services is proud to be an Equal Employment Opportunity and Affiliate employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.