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Director/Sr. Director of Quality Assurance

  • Job type: Permanent
  • Location: Raleigh
  • Salary: $200000 - $250000 per annum
  • Job reference: ARTR020518
  • Sector: EPM Scientific, Quality
  • Date posted: 09/02/2018
Director/Sr. Director of Quality Assurance
  • Director/Sr. Director of Quality Assurance
  • Raleigh, NC
  • $200,000 – $250,000 + excellent bonus + excellent benefits

We have partnered on a search for a Director/Senior Director of Quality Assurance with a biotech start-up based in Raleigh, NC. This company is focused on pioneering genetic solutions to treat various CNS related conditions. Our client has just received FDA approval for one of its indications to enter the first stage of clinical trials so this is the perfect opportunity to get in with an exciting company with many opportunities for growth as their drugs enter the later stages of clinical trials.  

The Director/Senior Director of Quality Assurance will have the following responsibilities:

The Director/Senior Director of Quality Assurance is responsible for the strategy, implementation and leadership of the Quality organization and is accountable for the continuous development, execution and administration of a comprehensive GxP Quality System meeting all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH and EMA regulations.
  • Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
  • Quality management of CMOs, CROs, contract test laboratories and other vendor services to ensure compliance with manufacture and testing of company products.
  • Establish and maintain phase appropriate GMP compliance for product manufacturing, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
  • Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.

The ideal candidate will have the following skill set:
  • Minimum of 12 years experience Quality Assurance and 8 years GMP Manufacturing experience
  • Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
  • Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
  • Excellent communication skills
  • Managerial experience 
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