Manager, Quality Audit

4 weeks ago

Raleigh, North Carolina, United States YPrime Full time

At YPrime, we help our clients in the pharma and biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups, and dispense clinical trial drugs and supplies using web apps. We're supporting life-altering research, one project at a time.


Is your career in its prime? It could be

YPrime's Quality team is searching for a Quality Audit Manager to help manage YPrime's sponsor and client audit program, and to help lead and drive the organization's execution of a global regulatory and quality strategy. You'll be based in our Raleigh, North Carolina office.

At YPrime, we help our clients in the Pharma and Biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups, and dispense clinical trial drugs and supplies using web applications. We're supporting life-altering research, one project at a time.

Does our mission sound like something you can get behind? If so, here's what we need from you:

  • A minimum of 6 years' experience in a Quality Assurance/ Quality Control role within a regulated, software environment
  • Advanced-level understanding of quality management systems, including the writing of policies and procedures, auditing techniques and FDA regulations for clinical trial software
  • Experience hosting and/or conducting audits of computerized systems within a clinical trial context
  • Excellent client facing communication skills with ability to manage issue escalations, conflict negotiations and influence
  • Excellent computer system validation, CAPA, Deviation Documentation, and Auditing skill

Have these things too? Even better

  • Bachelor's Degree
  • Experience in leading company-wide continuous improvement initiatives
  • Extensive experience working in highly regulated GCP environments

Here are some more details about the job:

  • You'll create and reinforce a culture of quality within the company by being recognized as the subject expert of company compliance and the champion of continuous improvement and customer satisfaction
  • You'll review, recommend, and lead the establishment of additional quality initiatives and/or quality systems for other areas of the organization, leading to improved customer satisfaction, improved efficiencies, and lower costs of operation
  • You'll directly manage and ensure progress of audit team towards individual and department goals and initiatives and ensure staff qualifications remain current to defined standards
  • You'll directly manage customer (Sponsor/client), internal and vendor audits
  • You'll drive company-wide continuous improvement initiatives to improve customer satisfaction, product quality and cost of quality
  • You'll establish and review internal measurements and metrics for product and service quality that support our mission and lead to extraordinary customer satisfaction
  • You'll prepare and/or review product and process quality reports by collecting, analyzing, and summarizing information and trends, and collaborates with others to continually improve these operations
  • You'll lead root-cause and corrective action investigations from audits and reporting and reviews efficacy of corrective actions, leading to overall reduction or elimination of non-conformances
  • You'll complete audit and compliance requirements by training Quality Audit Team and monitoring their performance
  • You'll maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
  • You'll support the company and customers during external inspections including audit assessment and QMS-related RFI question completion, as required
  • You'll support/perform and/or lead Client (Customer), Internal, Regulated Body or Vendor Qualification audits, as required

What are the Prime Perks?

  • Generous paid time off
  • Comprehensive benefits package largely subsidized by YPrime
  • Flexible working arrangements with an emphasis on work/life balance
  • 401(k) with company match
  • Friendly, smart, passionate, and hard-working coworkers
  • Opportunities for professional growth and advancement

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