Posted to MedZilla on 12/16/2017


ProClinical

United States, Director, Quality Assurance, GCP QA_MT_13669-MZ


 
 

If you are looking for an exciting new career path, ProClinical is seeking to fill a Director of Clinical Quality Assurance position, based in Cambridge, MA. The role includes providing leadership and guidance to our client’s clinical staff, to assure that research is conducted in compliance with applicable requirements. Additionally, the role will encompass management of a clinical and preclinical vendor qualification program, and assistance with inspection preparedness. This role is permanent, and whosoever fills it will report to the Senior Director of Clinical Quality Assurance.

Responsibilities.

  • Manage and oversee compliance, qualification and audit activities.
  • Ensure that audit plans are implemented, in order to provide assurances that clinical and preclinical studies managed by our clients are of the highest quality standard.
  • Ensure that audit results are formally and consistently recorded and reported.
  • Manage vendors and CROs during auditing.
  • Provide document authorship and submission assistance.
  • Assist with training at investigator meetings and internally.
  • Oversee inspection preparedness, including mock audits.
  • Assist in managing complaint handling and investigation systems.
  • Oversee quality aspects of clinical and preclinical validation activities.

Skills And Requirements

  • Bachelor’s degree/equivalent experience in a related field.
  • Demonstrated experience in implementing and managing quality systems.
  • Demonstrated experience conducting audits and/or hosting regulatory authority inspections.
  • Hands on experience with auditing, including methods validation.
  • Strong knowledge and understanding of drug development and the clinical trial process.
  • Strong understanding of current regulatory requirements (experience with global regulations preferred).
  • Excellent interpersonal and leadership skills.
  • Excellent problem-solving and analytical skills.
  • Strong communication skills.
  • Go-getter.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 6468786308 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.