Director, Product Quality Assurance

Job Location US-PA-Pittsburgh | US-MA-Boston
Mon-Fri, 9-5
Regular Full-Time


ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.


We are looking to hire a Director, Product Quality Assurance for our Pittsburgh or Boston office. In this role you will manage all quality assurance activities and staff to ensure corporate compliance with regulatory authorities and industry expectations. You will be ensuring adequate quality monitoring procedures are implemented to proactively identify and resolve quality issues. In this role you will create an environment conducive to continuous quality improvement and support continuous improvement activities. And you will monitor corrective and preventive actions and implement systems to nurture quality excellence.



  1. Develop and manage corporate quality assurance programs to assure compliance of ERT business processes with respect to applicable regulatory requirements (specifically 21CFR Part 11, Good Clinical Practices and the Computerized Systems used in Clinical Trials Guidance)
  2. Manage and perform corporate audits and assist in corporate functions.
  3. Serve as primary contact in the preparation, conduct and follow up of Sponsor and Regulatory Agency audits.
  4. Define annual audit schedule and oversee the conduct of ongoing audits of the following to assess compliance with ERT SOPs, Sponsor requirements and Regulatory Authorities:
  • Internal Processes
  • Project specific processes//requirements
  • Computer Systems
  • Vendors
  1. Review all Audit Plans and Audit Reports. Maintain the status of all audit findings in the Quality Assurance database and ensure prompt resolution.
  2. Perform tracking/trending analysis of audit findings and assist operations in the implementation of corrective action plans, as appropriate.
  3. Develop and maintain the following quality documents/systems:



  • Standard Operating Procedures
  • Audit database
  • Annual Audit Schedule
  • Annual Quality Program


  1. Perform a quality assurance review for all SOPs as well as manage the annual SOP review and update process.
  2. Author corporate and quality assurance standard operating procedures as required.
  3. Conduct ongoing internal meetings to monitor internal quality programs and issues.
  4. Provide Annual Quality Training Courses (e.g. Good Clinical Practices, etc.) as necessary.
  5. Serve as the liaison with Sponsors and other external partners with regard to quality issues and in support of regulatory inspections.
  6. Provide management summary reports of all audit activities.
  7. Provide consulting services to contracted external sources 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.  ERT reserves the right to amend or change this job description to meet the needs of the company.  This job description and any attachments do not constitute or represent a contract.






  1. College Degree in Health/Life Sciences; BA degree commiserate with experience will be considered
  2. 10 years experience in Good Clinical Practices and/or equivalent time and experience in Clinical Research; knowledge of regulatory authorities
  3. Thorough knowledge of the drug development process, software development practices, scientific terminology, quality systems, quality assurance procedures and policies
  4. 3-5 years previous management experience
  5. Ability to drive organization to achieve quality goals
  6. Excellent organizational and communication skills; Strong leadership ability



ERT is an equal opportunity employer and all qualified applicants 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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