Manager, Internal/Vendor Audits

Job Location US-MA-Boston | US-PA-Pittsburgh
Monday- Friday, 9-5pm
Regular Full-Time


ERT is the leading cloud platform solutions provider that captures quality efficacy and safety endpoints, harmonizes data from any clinical source system, and delivers real-time insights for optimum trial performance – innovating better health for over 40 years and tomorrow. ERT’s combination of technology, services, and consulting increases the accuracy and reliability of patient data and improves the efficiency of the clinical development process throughout the product lifecycle.  ERT provides sponsors and CROs with the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments (COAs including patient, clinician, and observer reported outcomes).  ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.


Our Boston office is looking for a Quality Assurance Manager to manage all Quality Assurance GCP auditing and related Quality Management Systems activities and staff to ensure corporate compliance with regulatory authorities and industry expectations.  To ensure adequate monitoring procedures are implemented to proactively identify and resolve quality issues.




  1. Manage Quality Assurance GxP Auditing personnel for the conduct of internal audits of the following to assess GxP compliance with ERT SOPs, ICH Good Clinical Practices, and EN ISO 9001, ISO 13485, Sponsor requirements, and regulatory authorities:
      • Internal departments/processes
      • Project specific processes/requirements
      • Computer systems
      • Vendors
  1. Manage and perform internal audits and gap analyses to ensure compliance with ERT SOPs, ICH Good Clinical Practices, and ISO 9001, ISO 13485 and applicable regulatory requirements for all ERT cardiac safety, respiratory, eCOA and technical operations. Develop auditing plans and reports for assigned audits. Maintain the status of identified audit findings in the Quality Assurance Database/CAPA Tracking System.
  1. Perform tracking/trending analysis of audit findings and assist operations in the implementation of corrective action plans, as appropriate. Manage corrective action and preventive action responses received for internal and external audit observations. Perform continued maintenance to ensure timelines are current.
  1. Support Continuous Improvement program through management of issues to ensure accurate root cause analysis, correction, corrective/preventive action implementation and confirmation of effectiveness. Manage communications with the management to ensure proactive oversight to issues and trends.
  1. Assist with the management of ERT controlled document management system and ERT controlled documents including but not limited to ERT Corporate Procedures, Standard Operating Procedures and ERT Policies.
  1. Author Quality Assurance/Regulatory Affairs standard operating procedures as required. Assist with the development and implementation of department specific ERT Standard Operating Procedures.
  1. Assist with the hosting and management of client audits. Analyze observations identified and generate effective responses.
  1. Perform routine quality reviews of key documents defined by ERT's System Development Life Cycle specifically related to:
      • Medical Device Development/Change Control
      • System Requirements
      • Testing/Validation Records
      • Installation Qualification
      • System Maintenance Records
      • Migration Records
  1. Manage corporate quality assurance programs to assure compliance of ERT business processes with respect to applicable regulatory requirements.




  1. Conduct ongoing internal meetings to monitor internal quality programs and issues.
  2. Provide SOP Development & Implementation, Annual Quality Assurance and Regulatory Affairs Training Courses to ERT staff, as necessary.
  3. Provide consulting services to contracted external sources as required.
  4. Assist in the development or execution of system testing as required.


The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.



  1. Bachelor's Degree in Health/Life Sciences; BA degree commensurate with experience will be considered
  2. 5-7 years QA/RA Experience
  3. Minimum 3 years previous management experience
  4. Knowledge of ICH GCP, 21CFR Part 11, 21 CFR 820.20, ISO 9001, ISO 13485 and applicable regulatory authorities.
  5. Excellent leadership, analytical, organizational and communication skills
  6. Detail oriented.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 


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