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Principal Quality Assurance Auditor (Service Leader)

Principal Quality Assurance Auditor (Service Leader)

ID 
2017-1353
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Service Leader, Quality Assurance (QA), will provide strategic direction and leadership to Rho’s QA team. In addition to delivering excellent quality assurance-related solutions to both internal and external customers, the Service Leader will also be responsible for building and maintaining a team of QA professionals, developing effective working relationships both inside and outside the company, and providing QA-related coaching and mentoring at all levels of the company.

Responsibilities

  • Providing leadership to corporate strategic initiatives with a QA component and guidance to Rho’s senior management on the implications of GCP or other applicable regulations on Rho’s business
  • Recommending and implementing risk mitigation strategies related to identified compliance issues
  • Providing regular and robust communications to senior management and internal stakeholders regarding ongoing QA initiatives and metrics
  • Keeping abreast of GCP or other regulatory developments and then creating an integrated plan for professional development and training activities to bring this knowledge to the organization
  • Recommending, implementing, and evaluating QA process improvements
  • Providing QA-related technical mentoring to the organization
  • Understanding customer and stakeholder needs and crafting strategic and tactical QA solutions that not only fulfill their needs but that are also compliant with GCP or other applicable regulations
  • Modeling Rho’s Core Values
  • Demonstrating knowledge and providing technical oversight of all QA-related processes (e.g., sponsor, vendor, and clinical site audits; regulatory agency inspections; software and system validation documentation audits)
  • Performing all QA-related processes as needed, as the working manager
  • Providing a nurturing and supportive work environment for all QA professionals; guiding QA professionals and providing consistent “in the moment” feedback (both positive and corrective)
  • Creating professional development plans for QA professionals
  • Ensuring the availability of QA staff with the necessary skill sets to address emerging issues; guiding and adjusting QA workflow and project assignments in response to business needs; delegating appropriately
  • Supporting business proposal preparation
  • Preparing training materials and conducting training related to relevant QA topics

Qualifications

BA/BS in life sciences, social sciences, liberal arts or a related degree and at least 10 years of increasingly responsible experience in clinical (GCP) quality assurance. Certification in clinical research, regulatory affairs, or auditing (CCRP, RAC, etc.) preferred. The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment. Candidate must be able to multi-task. The successful candidate will possess a wealth of knowledge of and experience with GCP and other regulations coupled with a flexible, collaborative attitude toward process development. Candidates must possess strong business acumen; excellent written and verbal communication skills; and strong Excel, Word, and PowerPoint skills. The candidate must be able to work independently as well as a member of a team. Prior QA experience supporting professional services within the biotechnology or pharmaceutical industry is preferred.