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Manager Quality Assurance GCP

Clinical Pharmacology
Hudson , NJ, NONE
  • Added - 22/02/2024
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Our client located in Hudson County, NJ is seeking a Quality Assurance Manager for their Clinical Operations Group. The ideal candidate will have a Bachelor’s degree in a scientific field and a minimum of 5 years of experience in a CRO environment.

Location: Hudson County, NJ
Type: Direct hire


  • Bachelor's degree in Science, Nursing, or a related field.
  • Proficient understanding of GCPs, ICH guidelines, and FDA regulations pertinent to Clinical Research, along with demonstrated experience in Clinical Quality Assurance.
  • Familiarity with the drug development process, GLPs, and GMPs.
  • Knowledge of ISO 27001 is advantageous.
  • Understanding of 21 CFR Part 11 and validation of computer systems.
  • Proficient in Microsoft Office suite, including Word, Excel, and PowerPoint.
  • Outstanding organizational, communication, writing, and time management skills.
  • Minimum of five (5) years of experience in clinical research within CRO pharmaceutical, biotech, medical device, or other life science industries, or an equivalent combination of education and experience.
Specific Responsibilities:
  • Conducts independent internal quality reviews of conducted studies and ensures clinical systems audits are conducted according to the audit plan.
  • Oversees and provides guidance on the development of Standard Operating Procedures (SOPs), Guidelines, and other relevant tools.
  • Performs external audits at investigational sites (as required) to ensure compliance with GCPs, ICH guidelines, FDA regulations, SOPs, and study protocols.
  • Facilitates regulatory agency inspections/sponsor audits and formulates responses to audit report findings following discussions with operations management.
  • Collaborates with the quality team and management to address internal and external audit findings, rectify deficiencies, and implement preventive actions.
  • Leads investigations into study conduct and non-conformance issues, formulating and monitoring Corrective and Preventive Action Plans (CAPAs), and ensuring their effectiveness.
  • Tracks and analyzes audit findings and investigations, assesses compliance risks, and escalates them to site management as necessary.
  • Initiates and manages quality metrics and trending analysis, presenting findings to management appropriately.
  • Keeps department management informed of new or updated regulations affecting CRC operations and provides training as necessary to ensure ongoing compliance with current quality and industry regulatory requirements.
  • Reviews and approves computer systems validation (CSV) documents (when applicable) to ensure compliance with internal procedures and regulatory requirements.
  • Evaluates procedures and processes affecting quality and proposes process improvement initiatives.
  • Represents clinical Quality Assurance as a management representative in the development of company policies and procedures.
  • Performs any other duties as assigned.