Diligent is an early-stage technology company that spun off from a successful and well-established business that was a pioneer in the clinical research industry. The organization has a mission-driven and values-driven culture that encourages entrepreneurialism, determination, and resourcefulness.
The Diligent Qualification Platform is a cloud-based technology and suite of services that enables Sponsors and CROs to rapidly identify, evaluate and select clinical service providers. Diligent addresses inefficiency and time delays in clinical trial execution and is the only company in the industry providing a solution to reduce redundancy around Vendor Qualification for clinical trials. Over 100 leading CROs, tech companies and service providers trust the Diligent platform to streamline their RFI (Request for Information) and VQA (Vendor Qualification Assessments) completion processes.
We are currently seeking a Lead Auditor. The ideal candidate will be able to work collaboratively in a start-up environment and must be able to work in a flexible manner, handling a variety of different tasks to fulfill revenue needs while also working to meet the broader strategic goals of the business.
The Lead Auditor is responsible for providing technical process oversight and managing the successful delivery of Diligent’s Vendor Qualification Assessments (VQA’s) and Vendor Audits (VA’s) through the use of the Diligent Qualification Platform (DQP) processes. This role works closely with both the Sponsors and Providers to plan, execute and report on VQA’s and VA’s. The day-to-day job responsibilities include, but not limited to:
- Provide process expertise and leadership to continuously improve the Diligent VQA and VA processes.
- Monitor performance metrics and identify process improvement opportunities.
- Lead process improvement projects that optimize both effectiveness, efficiency and cycle time reduction.
- Analyze Diligent VQA and VA Observation data to identify emerging trends and share learning with DQP leadership.
- Facilitate knowledge transfer to DQP Auditor community to strengthen the performance of all Auditors.
- Conduct training for new Auditors and mentor existing Auditors as a player-coach.
- Provide input into future DQP software requirement to enhance effectiveness, efficiency and cycle times.
- Maintain Knowledge of Global Regulatory Requirements for GCP Vendors
- Maintain knowledge of current requirements that impact and apply to GCP Vendors from all Regulatory Agencies including but not limited to: FDA, EMA, MHRA, PMDA, CFDA, KFDA.
- Maintain knowledge of Avoca Quality Consortium (AQC) Vendor Qualification Standards
- Maintain working knowledge of Regulatory enforcement actions related to Sponsors and Vendors provided GCP products and/or services.
- Prepare for Assigned VQA or VA Sessions
- Participate in Sponsor Scope Planning meetings to define the VQA or VA Scope.
- Develop and communicate the Confirmation Letter and Draft VQA/VA Agenda to assigned Vendors.
- Review available completed RFI’s from assigned Vendor
- Ensure VQA/VA Agenda is finalized with logistics including Web-conference Meeting Invitation and access to Document Sharing Repository
- Review available documents in Document Sharing Repository before scheduled VQA/VA meeting.
- Conduct the assigned VQA or VA Sessions
- Initiate the VQA or VA session on-time with the stated intent of the evaluation.
- Evaluate presentations and interview responses for compliance with the AQC’s Vendor Qualification Standards that apply to the Vendor
- Probe with questions to interviewees to fully understand the Vendor’s Quality Management System (QMS) and associated processes.
- Note any observations or topics for follow-up that don’t align with Global Regulatory requirements or AQC Vendor Qualification Standards.
- Develop a summary of Observations for readout to Vendor staff at the conclusion of the VQA or VA.
- Conduct Readout Summary at the conclusion of the VQA or VA.
- Notify Head of Services immediately if an Observation is deemed to be a Critical severity. SOP’s require that a Sponsor be notified immediately and a special meeting be scheduled to provide a verbal update on any potential Critical Observations.
- Author the VQA or VA Report
- Utilize the most recent VQA or VA Report Template as the starting point for a new VQA or VA Report
- Delete any template paragraph sections that do not apply to defined scope.
- Describe the assessment findings in each prescribed paragraph of the Report Template. Please include Tables that list QMS documents, Equipment, and other Process Documents that were reviewed within the body of the VQA or VA Report. Where possible, please include a reference to the applicable Regulation that was not met.
- Document any Observations in the Observation Section of the Report that do no meet applicable Global Regulatory requirements or AQC Vendor Qualification Standards.
- Provide helpful suggestions to Providers as to how best to address identified gaps listed as Observations.
- Upload draft VQA or VA Report into Teams folder and the DQP
- Adjust VQA or VA Report with Editor or Sponsor Feedback
- Adjust the VQA or VA report to address feedback or comments from either the Diligent Editor or Sponsor personnel.
- Ensure all comments and feedback are addressed completely.
- Manage Vendor Corrective Action / Preventive Action (CAPA) Response Process
- Provide the Draft VQA or VA Report after 1st draft editing, to the Provider with instructions for completing their CAPA commitments for identified Observations (if applicable)
- Communicate follow-up checks with Sponsor to ensure delivery of a timely CAPA response.
- Review the Providers CAPA response to ensure it addresses the applicable Observations.
- Communicate any feedback to the Provider to improve the CAPA response to be adequate to address the Observations if initial response is inadequate.
- Communicate to Head of Client Services that the draft report with CAPA is ready for Final Sponsor Review once Provider CAPA commitments are adequate.
- Complete Final Approval and Documentation
- Edit VQA or VA report to finalize any last feedback and format appropriately.
- Ensure VQA or VA report is sent out for final signatures
- Once approved, file the approved report in Teams and initiate final redaction with Editor.
- Ensure the redacted VQA or VA report is uploaded to Teams folder.
- Upload approved and redacted VQA into the DQP as the final repository of the completed work product.
- Serve as backup to other Diligent Operations Team roles when required due to absences, vacations, extended leaves or vacancies.
- Other duties as assigned by Head of Diligent Professional Services
Skills & Experience Required
- Minimum of Bachelor’s Degree required, Advanced Degree preferred.
- At least 15 Years experience in Quality Assurance, Quality Control, and/or Auditing.
- Minimum of 10 years Auditing Experience is required.
- Strong written and verbal communication skills
- Strong interpersonal skills
- Strong analytical skills with high attention to detail
- Strong capability utilizing Microsoft Word, Excel and Powerpoint