📁
Quality
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20005031 Requisition #

Summary:          

 

Partners with our internal and external customers, providing them with expert support based on a deep understanding of current global Good Clinical Practice (GCP) requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction.

 

 

Essential Functions:

 

1.   Provides strategic quality oversight for up to 2 strategic alliance accounts.

 

2.   Partners with the designated Strategic Alliance Management Lead and the customer Quality representative to develop and execute a Quality Management Plan that will meet the needs of the customer.

 

3.  Supports the internal alliance and operational teams to ensure quality delivery and continuous improvement.

 

4.  Meets with the designated Strategic Alliance Management Lead and the customer Quality representative on an ongoing basis to review the state of quality of the program based on key quality metrics.

 

5.  Partners with the designated strategic alliance management Lead to ensure that quality issues that occur within a study or a site are resolved across the partnership.

 

6.  Acts as the Corporate Quality point of contact in the designated partnerships for quality issue escalation.

 

7.  Works with the internal Quality Analytics Specialist to obtain key reports and metrics and converts these into presentations for steering committee meetings for the alliance partnerships.

 

8.   Provides  internal support for Quality Issues that arise on the aligned alliance partnerships

 


Requirements:

 

  • BA/BS degree or equivalent combination of education and experience.

  • Extensive, management experience in a global clinical research, pharmaceutical, or Biotechnology Company.  

  • Thorough knowledge of drug development and ICH GCP Guidelines is necessary.  

  • Experience in quality management and/or process improvement is essential.  

  • Comfortable working closely with customers and communicating with executives.  

  • Effective at conflict resolution.  

  • Highly effective strategic planning, communication, written, presentation and analytical skills.  

  • Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required.  

  • Experience working in a matrix team environment is preferred.  

 

Disclaimer:

 

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.


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