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We are seeking a Territory Quality Manager to join our team.

This is a remote position with some travel involved as needed.

 

#LI-JD1

  • Establishes quality compliance at site level across the territory and ensure maintenance of the process.
  • Actively contributes in the selection process of Partner Sites, following relevant procedures for approval and oversight.
  • Effectively manage quality compliance with Standard Operating Procedures (SOPs) at Affiliated and Partner Sites.
  • Provides quality-focused support to the business to achieve regulatory compliance and commercial objectives.
  • Support the reporting and follow up of Quality Issues and CAPAs within the region.
  • Support the region to prepare and host internal and external audits and inspections.
  • Identifies Operational Compliance performance metrics on data generated and provides required metrics/RAG reports to management, as appropriate.
  • Provides training on functional GCP, and other compliance and quality related topics, as required, to improve quality and expertise within the operation of the regional research centers.
  • Ensures site compliance with  SOPs, GxP, and all applicable regulatory body guidance and international standards.
  • Safeguards confidentiality of staff, patient and sponsor matters as required by regional GDPR or HIPAA and Good Clinical Practice expectations.
  • Act as a resource to ensure that patient safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g. audit reports inspection output, complaints)
  • Provide quarterly quality plans and monthly reports and have regular meetings with TD and site management regarding site performance, reported QIs, consultations
  • Support and review Root Cause Analysis and CAPA investigations on a site level     
  • Approximately 30% travel
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years)
  • Good knowledge of the Regulations and ICH, GCP

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 

We offer a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!  

We are an Affirmative Action and Equal Opportunity Employer.

Accelerated Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of  AES services include strategic enrollment solutions that offer speed, certainty and commercial value to our clients. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.