Quality Assurance Manager, Clinical Services

Quality Assurance Manager, Clinical Services

Secaucus, NJ

Reports to: Global Head of Quality, dotted line to Head of Frontage Clinical Services, Inc.

Duties

  • Responsible to lead/execute the overall design, implementation and maintenance of a robust and effective Clinical Quality program to support Frontage and BDM clinic, data management and biometrics
  • Primary host for all regulatory inspections and client audits and works with operations management on the response and follow-up to completion
  • Conducts internal audits in accordance with procedures

Qualifications

  • Bachelor’s degree in a scientific/regulatory discipline
  • Additional training or experience in regulated clinic operations and quality assurance is required
  • Team player, detail oriented and organized, good interpersonal skills, technical writing and computer skills including Microsoft Office

Experience

  • Work experience as Clinical Quality leader in biopharmaceutical companies and/or contract research organizations, hosted regulatory inspections, working knowledge of the drug development process, GCP/ ICH guidelines and FDA/EMA regulations

Specific Responsibilities

  • Hosts regulatory agency inspections/sponsor audits and issues responses to audit report findings after discussion with operations management
  • Conducts internal review of studies performed at the Frontage Clinical Research Center (CRC); Frontage CRO services (including BDM Consulting) and ensures the conduct of clinical systems audits are performed per audit plan.
  • Oversees and advises on the development of Standard Operating Procedures, Guidelines and other tools to support the Frontage CRC
  • Leads and oversees the training program and collaborates with operations management to ensure staff training is current as required by their role
  • Conducts GCP training at least annually and serves as mentor to junior team members
  • Identifies training needs and delivers the training material to meet quality standards
  • Performs external non-Frontage investigational sites audits (as needed) for compliance with GCP and ICH guidelines, applicable FDA regulations, SOPs, and the study protocol
  • Reviews and approves computer systems validation (CSV) documents to ensure compliance with internal procedures and regulatory requirements
  • Works with quality team and management to ensure internal and external audit findings are addressed, deficiencies are corrected and preventive actions are implemented
  • Leads study conduct investigations and non-conformance issues
  • Develops, recommends and monitors Corrective and Preventive Action Plans (CAPAs)
  • Performs effectiveness verification to ensure CAPAs were implemented
  • Evaluates procedures and processes affecting quality and proposes process improvement initiatives
  • Tracks and trends audit findings, investigations, assesses compliance risk and escalates to site management appropriately
  • Initiates and manages quality metrics and trending analysis, and presents findings to management appropriately
  • Updates department management on new/updated regulations affecting CRC/CRO operations and provides training as appropriate to ensure ongoing compliance with current quality and industry regulatory requirements
  • Represents Clinical Quality Assurance as a management representative for development of company policies and procedures
  • Supervise/mentor junior clinical QA staff Other responsibilities as assigned

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