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Senior Quality Director

  • Job type: Permanent
  • Location: Ireland
  • Salary: €135000 - €155000 per annum, Benefits: 10% Annual Bonus
  • Job reference: Quality Director
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 13/12/2017
The Job:


A Leading Biotechnology company is seeking an experienced Senior Quality Director based in Ireland, Limerick.


This is a senior position that will involve taking on the responsibility for the Quality Assurance department. 


This is a chance to be part of a rapidly growing organization with an amazing pipe-line. The company, although young has already established itself on the market and is looking to continue to grow its Quality department and site, into one of the key players in the Biotechnology industry. 


The company is award winning and has been consistently ranked a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies.


The main aspects of this role will involve the candidate to be responsible for the growth and implementation of the strategy and design for the Industrial Operations and Product Supply quality function.


Responsibility includes providing direction to the functional area to ensure first-class, safe and operative products that are compliant with global regulatory requirements.


Responsibilities:


Implement a quality system based on various aspects surrounding sound science and suitable quality, regulatory and legal requirements.


Check the performance of the quality system using the appropriate tools to measure and demonstrate a assurance to continuous improvement


Embed quality tools and risk management processes with the quality system


Stay up to date with changing requirements/expectations and address with the quality system.


Use quality and risk management tools to make timely and educated decisions to protect patient safety.


Team management responsibility


Skills and Experience Required:


BS or higher in Engineering, Chemistry, Biology or related science/technical field; MS in science/technical field / QP Qualification would be an advantage.


Minimum of 10 years’ experience in a pharmaceutical/biotechnology manufacturing environment with 5+ years’ experience in a managerial role.


Experience with facility start-up, validation, Pre-Approval Inspections, and product launch activities is desired.


Extensive knowledge of GMPs and GLPs; current knowledge and/or experience with QA systems such as change control, investigations (manufacturing/laboratory), deviations, CAPA, document management systems, etc


Extensive  knowledge of quality expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations and guidelines, particularly CMC and GMP


Has the ability to deliver things as quickly and efficiently as possible


The ability to work efficiently, and effectively in a rapidly growing and undefined environment.


What this Job Offers You:
  • Senior Career Development
  • Competitive salary 
  • Relocation package
  • 30 days holiday (inclusive of bank holidays)
  • Pension Plan & Healthcare
 


How to apply:


Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact:  apply.a33ho1gkmiy@epmscientific.aptrack.co.uk or phone +442037588828


 


 


 

 



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