Quality Assurance Manager

Pennington, NJ 08534

Posted: 08/23/2019 Industry: Quality Control Job Number: 9102 Pay Rate: $110,000 - $120,000/yr.

RESPONSIBILITIES

  • Develop, direct and implement Quality Systems/Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements.



  • Ensure that Clinical studies are conducted in compliance with study protocols, GCP, GLP and federal guidelines.



  • Manage the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs.



  • Understand quality by design and implement a risk-based approach in auditing process. Responsible for the auditing of clinical trial sites (Investigators) during various phases of a clinical research study (as applicable), vendors and contract research organisations.



  • Stay updated with Quality Assurance and regulatory trends, develop and implement recommendations regarding actions necessary to assure ongoing compliance.



  • Provide guidance and training to the investigator sites /Clinic team as when required.



  • Perform all activities in compliance with company SOPs, safety standards, study protocols, GCP and regulatory requirements



  • Audit data and clinical study reports. Conduct in-process, on-site process and facility audits, and serve as a resource on the interpretation and application of regulations.



  • Participate and assist with regulatory inspections.



  • Prepare and retain written reports on audits, inspections and disseminate them to Quality Management, Head of Clinic and appropriate personnel.



  • Assess the adequacy of responses (CAPA plans) to audit findings.



  • Review and approve Installation Qualification (IQ) and Operational Qualification (OQ) documents relating to concurrent validation activities as and when required.





QUALIFICATIONS

  • Bachelor s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field



  • Minimum 5 years experience in clinical trials /GCP auditing (preferably 3 years in GCP Auditing).



  • Complete knowledge of GCP standards and regulations.



  • Strong observational, analytical, and communication (written and verbal) skills.



  • Collaborative skills and ability to work independently



  • Experience in Quality Management and Computer System Validation.



  • Flexible to travel up to 30%.


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