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REMS QA Consultant

Company: Green Key Resources
Location: Somerville
Posted on: May 14, 2022

Job Description:

We are seeking a consultant to support our clients Risk Evaluation & Mitigation Strategy (REMS) QA audit program. This individual will work cross-functionally with the REMS Compliance and Operations teams to plan, conduct, evaluate, and report compliance/audit outcomes. The auditor will be critical to supporting ongoing audit commitments and ensure that the REMS program meets regulatory and business requirements.Roles and ResponsibilitiesProvide quality audit support for the REMS program.Assist in oversight of REMS audits of certified Healthcare Settings (HCS) to ensure they are conducted in a timely manner and meet REMS requirements; escalate and evaluate compliance critical events as appropriate.Plan, conduct, and report on assigned REMS audits of Specialty Pharmacies (SPs), Specialty Distributors (SDs), and Healthcare Setting (HCS) to assess compliance with REMS requirements. -Ensure timely issuance of audit reports and audit observations, oversee the audit response process, and drive audits to closure.Ensure audit CAPAs, non-compliance events, program deviations, and change controls are reported accurately and completed in a timely manner.Ensure REMS Specialty Pharmacies (SPs), Specialty Distributors (SDs), and third-party vendors operate in compliance with the REMS requirements.Lead assigned REMS compliance initiatives aimed at strengthening the program, as required.Ensure REMS quality incidents are fully investigated, root cause identified, and CAPAs are appropriate, have been implemented, and are monitored for effectiveness.Provide data to assess risks, generate quality metrics, and review lessons learned as requested.Reporting of key metrics (KPIs), periodic quality reports, and audits as required.Other responsibilities as assigned.Experience, Education and Specialized Knowledge and SkillsMust thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and orchestrate plans to resolve issues and mitigate risks.Basic QualificationsBS/BA or science degree and experience working in Quality.2+ years of Quality experience, specifically auditing.Preferred QualificationsA combination of Quality and technical experience (GCP, GVP, REMS, and auditing).Understanding of regulatory requirements for the implementation and maintenance of a REMS compliance program.Understanding of REMS guidelines.Experience authoring compliance sections of REMS Assessment Reports is preferred.Practical application of regulatory requirements (e.g. 21 CFR Part 210 and 211, and 21 CFR Part 11, 505-1 (REMS)).Experience with REMS inspections.Experience building internal and external relationships and working with external vendors.Excellent interpersonal and problem solving skills.Ability to coordinate timelines with internal customers, external clients, and vendors.

Keywords: Green Key Resources, Somerville , REMS QA Consultant, Professions , Somerville, Massachusetts

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