Quality Assurance Manager

Celerion Tempe, AZ

About the Job

Celerion is looking for a Quality Assurance Manager to provide daily guidance and supervision to quality assurance staff for our Early Clinical Research and Global Clinical Development divisions. This role can be based in either our Phoenix, AZ or Lincoln, NE facility and will require 30% travel to both domestic and international locations.


Quality Management System

  • Staff management of quality assurance staff and daily guidance
  • Primary contact to support implementation of QMS LOS
  • Drive quality process improvements initiatives
  • Change management advocate for staff
  • Oversee metric analysis
  • Oversee quality issues resolution

Client Audits and Regulatory Authority Inspections

  • Oversee and participate in the preparation and execution of client audits and regulatory authority inspections
  • Coordinate all activities during client audits and/ or regulatory authority inspections
  • Track observations/ findings from client audits and/ or regulatory inspections
  • Coordinate the action items and responses for client audits and/ or regulatory authority inspections

System-based Inspection (internal and external audit)

  • Oversee external supplier/ supplier qualification audits and issue the audit findings in a written report to management
  • Oversee internal systems-based audits/ inspections and issue the audit findings in a written report to management

Manage Daily Quality Assurance Activities

  • Primary contact for auditing of reports, source documents, and study source data to assure compliance with protocols, procedures and applicable regulatory requirements and guidelines
  • Ensure audit reports to assure the results accurately reflect the study source data generated during the study
  • Oversee live event audits of studies in progress
  • Interact with internal clients to discuss QA observations
  • Lead and participate in the review and/ or the writing of SOPs as required
  • Coordinate and/ or facilitate local regulatory training
  • Oversee audit findings in a written report format for each study phase audited and maintain QA files and records accordingly
  • Monitor and evaluate follow-up on corrective and preventive actions
  • Quality check events, deviations, investigations and change control documentation
  • Bachelor's degree in Business, Science or related field
  • Minimum 5 years experience in QA
  • QA Management experience required
  • Proficient knowledge and training experience of GCP, GLP, Part 11 regulations and related guidelines as well as local regulatory agency regulations is required
  • Excellent oral and written communication skills
  • Ability to organize and manage multiple priorities
  • Good time management skills
  • Attention to detail, tactful and diplomatic
  • Computer proficiency with MS Office products

EEO/AA M/F/Vet/Disability