Posted to MedZilla on 8/21/2017


ProClinical

United States, Senior Director of Corporate Quality US_QA_MT_13045-MZ


 
 

A blood plasma biotechnology company is seeking a Senior Director of Corporate Quality to join their team in Austin, Texas. The company prides itself on high quality products that it supplies to pharmaceutical companies worldwide. 

Job Role:

The purpose of this position is to establish strategic policies and procedures to ensure the company is operating within industry regulations to deliver a safe and cost effective product. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

Job Responsibilities:

  • Establishes quality systems, policies, objectives, initiatives and organizational structures to support corporate quality.
  • Develops departmental strategic plans, budgets and goals.
  • Develops operational processes regarding quality system functions including Change Control, Document Control, Equipment and Computer Validation, Lookbacks and Deviations.
  • Manages departmental employees including training, performance evaluation, career development, compensation administration and progressive discipline as needed according to company policies and procedures.
  • Supervises the departmental managers including Change Control, Document Control, Equipment and Computer Validation, Lookbacks, Deviations and Quality Assurance Project Development and Implementation.
  • Manages departmental employees including training, performance evaluation, career development, compensation administration and progressive discipline as needed according to company policies and procedures.
  • Provides leadership and guidance to the Change Control Board.
  • Develops, tracks and trends quality system process improvement initiatives to ensure compliance with regulatory requirements.
  • Develops tracks and trends the customer notification process resulting from lookbacks and deviations.
  • Conducts regulatory scheduled staff meetings to discuss departmental operational status and provision of guidance.
  • Develops and monitors departmental and staff objectives.
  • Tracks and trends departmental performance for process improvements.
  • Provides technical support during internal/external audits and regulatory inspections.

Qualifications

  • Bachelor's degree in life science or related field.
  • Ten years' experience in biologics, biotechnology or pharmaceutical industry with increasing quality responsibilities; or equivalent combination of education and experience.
  • Five years' supervisory management experience.
  • Extensive knowledge of quality system regulations.
  • Strong written and verbal communication skills.
  • Plasma industry experience preferred.
  • Advanced quality certification preferred.
  • Occasionally required to travel overnight.
  • Frequently performs work while sitting.
  • Required to communicate and interact with employees and vendors.

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 Matt Tong on +1 646 768 9726 or upload your CV 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.