Quality Assurance Manager

Basking Ridge, NJ 07920

Post Date: 04/11/2018 Job ID: 8137 Industry: Pharma

SUMMARY

This position performs and manages an auditing schedule that encompasses all phases of clinical development and assures that all studies performed are compliant with GCP requirements. Duties of this role include supporting all aspects of GCP regulatory inspections internally at facilities as well as externally at service providers and investigator sites. This level also provides training to study teams on GCP requirements. Additionally, this position interacts with Quality Assurance functional and cross-functional teams and has contact with external auditees, e.G., vendors and study sites, and communicates with QA consultants. This position consults on procedural and study related issues and escalates issues of elevated risk to Senior Management. This position makes the majority of decisions based on the interpretation of established guidelines, regulations, and procedural documents which requires problem solving skills.



RESPONSIBILITIES

  • Performs and manages an auditing schedule that encompasses all phases of clinical studies.



  • Authors and updates Study Specific Audit Program documentation for assigned projects.



  • Conducts audits and related activities from preparation to writing and distribution of reports.



  • Collaborates with Consultant Auditor to ensure the performance of audit activities.



  • Assists in the review of Consultant Audit Reports.



  • Verifies, assesses, and tracks CAPA documentation and commitment implementation.



  • Evaluates impact of CAPA implementation when appropriate.



  • Generates requests and reminds relevant parties of follow-ups.



  • Interprets relevant regulations and applies these to Clinical Research and Development programs.



  • Supports intelligence collection, communicates, and presents findings on relevant topics to train on.



  • Supports GCP/GcLP regulatory inspections (internal) at facilities, investigator sites, CROs, and bio-analytical laboratories for US submissions and studies.



  • Prepares, coordinates, and tracks document requests, responses, and supporting documentation during inspections, and verifies response implementation after inspections.



  • Drafts QA policies, procedures, and standards.



  • Tracks and manages the review process of specific global and local Quality Assurance SOPs and policies and verifies the adherence to regulatory guidelines.



  • Collaborates with global QA teams in developing and implementing GCP/GcLP Quality Assurance objectives and schedules for audits of investigator sites, CROs, bio-analytical labs, etc. Based on risk considerations, elevates issues to Senior Management.



  • Also acts as an internal consultant by liaising with departments regarding global conformance with regulatory requirements, good clinical practice and internal standards, and the pro-active integration of quality and process improvement.





QUALIFICATIONS

  • B.S. Degree in scientific, health care, or related discipline or background in Medical Health Profession (RN, Medical technologist, etc.)



  • Five years of pharmaceutical experience





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