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We are seeking a Territory Quality Associate Director to join our team.

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

 

#LI-JD1

  • Support the TD to establish quality compliance at site level across the territory and ensure maintenance of the process.
  • Actively contribute to the selection process of Partner Sites, following relevant procedures for approval and oversight.
  • Effectively manage quality compliance at high-risk areas e.g. Affiliated 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 FDA, SOPs, GxP, and all applicable regulatory body guidance and international standards.
  • Safeguards confidentiality of staff, patient and sponsor matters as required by regional GDPR and Good Clinical Practice expectations.
  • Act as a resource to ensure 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    
  • 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 8+ years).
  • Mastery of the audit process, including audit preparation and oversight, sponsor, internal audits (regulatory authority and FDA will be advantage), as well as CAPA reporting and basic root cause analyses
  • Excellent understanding of the preparation of and collation of regulatory documents for ethics submissions
  • Mastery of theory and techniques in the data and compliance field
  • Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
  • In depth knowledge and understanding of the requirements, best practice and organization of a clinical research site.
  • Exposure to internal audits as well as Regulatory Body inspections
  • Excellent leadership skills, including mentoring and training other members of staff at all levels
  • Excellent interpersonal skills, including assertiveness, persistence, flexibility; highly organized and detail oriented

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.