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Associate Director - Quality

Associate Director - Quality

  • Location:

    Dublin 15, Ireland

  • Sector:

    Engineering & Life Sciences

  • Job type:

    Contract

  • Contact:

    Gillian Dunphy

  • Contact email:

    [email protected]

  • Contact phone:

    353 (0)1 960 9773

  • Job ref:

    21-11827

  • Published:

    about 2 months ago

  • Expiry date:

    2021-09-05

  • Startdate:

    2021-08-06

Associate Director – Quality Control
 
Are you an experienced Manager within Quality Control in a Biotech/Biopharma/Pharma manufacturing facility? Are you looking for your next big career move?  If you are interested in a fantastic opportunity working at an amazing company then keep reading!
 
This is a one-of-a-kind job with a world class pharmaceutical leader
 
This is a fixed term contract job based in Dublin.
 
 
What will you do in this job?
  • You will lead and manage the provision of analytical, bioanalytical, microbiological, and technical transfer expertise to the laboratories external to the company where their products are tested
  • You will oversee management of the labs contracted to the company in support of product release and manage the associated budget.
  • You will support maintenance of regulatory compliance through established programs for the oversight of laboratories external to the company and support the strategic efforts ongoing to align on their testing portfolio.
  • Lead a team of QC specialists/managers in support of contract lab management
  • Drive compliance and alignment across contract laboratories
  • Manage the budget for all contract lab activities to support commercial release and stability programmes
  • Support all product queries from the local and Global regulatory functions.
  • Oversee and manage the QC technical review and critique of documents for all new filing applications for company products.
  • Support the co-ordination and technical review of responses to agency questions on analytical methods.
  • Provide technical support to all new country launches that require in-country testing
  • Support method transfers and stability teams to contract test laboratories.
  • Work with all partners associated with the supply of products as part of end to end processes to ensure continued supply of product to markets.
  • Representative on change control review boards for all products to assess impact of all changes presented and follow up on assigned implementation activities.
  • Support operations of the Quality Control testing laboratories as requested by QC management (change controls/documentation reviews).
  • Support management in continual enhancement of the QC strategic plan
 
 
What do you need to be successful in this job?
  • B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
  • Preferable 8 – 12 year's experience within quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, 7 years of supervisory/ management leadership experience is preferable
  • Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
  • Proven record in demonstrating agility and building agile teams
  • Experience of involvement in technical issue resolution, in a multidisciplinary environment
 
 
What's in it for you?
  • A competitive salary with incentives/bonus.
 
And… much more!
 
 
The Next Step for you:
 
Interested in this role? Please send your CV to GILLIAN DUNPHY at Next Generation Recruitment by clicking on the Apply button!
 
Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there.
 
Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT.
 
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