EPA GLP Senior Consultant

ProPharma Group; United States; Hybrid; USD 75,000 - 105,000; Full time

Job summary

ProPharma Group is seeking a skilled consultant to guide EPA GLP readiness for a client site in the United States. The engagement begins with an initial consultation (about 10 hours) to outline EPA GLP requirements and assess current laboratory processes.

The project continues with a formal gap assessment (about 2 days on-site) focusing on analytical and microbiology laboratories, with actionable remediation recommendations and a clear roadmap for compliance.

Responsibilities

• Phase 1: Initial Consultation Approximately 10 hours; Review current laboratory processes and documentation; Define EPA GLP requirements applicable to the site; Confirm scope, objectives, and assessment criteria.
• Phase 2: Formal Gap Assessment Approximately 2 days on-site; Focused on analytical and microbiology laboratories; Evaluate laboratory controls, procedures, documentation, quality systems, and GLP-specific requirements; Identify compliance gaps and remediation recommendations; Deliver a prioritized summary of findings and next steps.

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.Client requires an initial consultation to provide a practical, plain-language overview of EPA GLP requirements and key differences from current GMP framework. Client also needs a focused gap assessment of the analytical chemistry and microbiology laboratories, as well as recommendations and a roadmap to support EPA GLP readiness objectives.Phase 1: Initial ConsultationApproximately 10 hoursReview current laboratory processes and documentationDefine EPA GLP requirements applicable to the siteConfirm scope, objectives, and assessment criteriaDevelop a detailed plan for the gap assessmentPhase 2: Formal Gap AssessmentApproximately 2 days on-siteFocused on analytical and microbiology laboratoriesEvaluate laboratory controls, procedures, documentation, quality systems, and GLP-specific requirementsIdentify compliance gaps and practical remediation recommendationsDeliver a prioritized summary of findings and next stepsThis phased approach allows requirements to be clearly defined before undertaking a targeted EPA GLP gap assessment.#LI-JH1#LI-ONSITEWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***