Manager, Quality Audit

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 or Malvern, Pennsylvania headquarters.

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 environmentAdvanced-level understanding of quality management systems, including the writing of policies and procedures, auditing techniques and FDA regulations for clinical trial softwareExperience hosting and/or conducting audits of computerized systems within a clinical trial contextExcellent client facing communication skills with ability to manage issue escalations, conflict negotiations and influenceExcellent computer system validation, CAPA, Deviation Documentation, and Auditing skill Have these things too? Even better! Bachelor’s DegreeExperience in leading company-wide continuous improvement initiativesExtensive 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 satisfactionYou'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 operationYou'll directly manage and ensure progress of audit team towards individual and department goals and initiatives and ensure staff qualifications remain current to defined standardsYou'll directly manage customer (Sponsor/client), internal and vendor auditsYou'll drive company-wide continuous improvement initiatives to improve customer satisfaction, product quality and cost of qualityYou'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 operationsYou'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-conformancesYou'll complete audit and compliance requirements by training Quality Audit Team and monitoring their performanceYou'll maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societiesYou'll support the company and customers during external inspections including audit assessment and QMS-related RFI question completion, as requiredYou'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 offComprehensive benefits package largely subsidized by YPrimeFlexible working arrangements with an emphasis on work/life balance401(k) with company matchFriendly, smart, passionate, and hard-working coworkersOpportunities for professional growth and advancement