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Director, Clinical QA

System One
Audubon, PA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Title:  Director, Clinical Quality Assurance 
Location:  Greater Philadelphia Area- Partial Remote 
Type: Full Time, Salaried with benefits  

 

Responsibilities:   

  • Oversight and lead Clinical Quality Assurance Team in planning, execution and analysis of internal / external audits for the Clinical Research and Development teams  
  • Oversee development and management of study specific audit plans and continuous improvement processes to support the quality of clinical studies and pharmacovigilance 
  • Leadership of a professional team (internal and consultants when required) focused on clinical quality assurance and compliance-related activities in support of clinical programs and activities.
  • Refine and maintain Clinical Quality System to ensure compliance to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) 
  • Actively lead (direct and/or participate) audit activities in the areas of internal & external clinical quality audits of clinical study sites both domestically and internationally, establishing Corrective and Preventive Actions (CAPA) for regulatory audits of clinical systems, quality management reviews, and supporting regulatory agency inspections.

Requirements:

  • Bachelors’ degree required; RN preferred 
  • 6+ years of experience in Clinical QA, 3+ supervisory/leadership experience -inclusive of performance of clinical quality assurance internal and external audits.
  • Regulatory experience as it relates to clinical study conduct is preferred.
  • Experience participating in clinical related inspections by the United States Food and Drug Administration, or other compliance agencies, preferred.
     

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

 

System One

Address

Audubon, PA
USA

Industry

Technology

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