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Associate Director of Quality Assurance

  • Job type: Permanent
  • Location: Burlington
  • Salary: $150000 - $160000 per annum
  • Job reference: BD081117
  • Sector: EPM Scientific, Quality
  • Date posted: 11/08/2017
Global CMO is looking for an Associate Director of Quality Assurance!
 

A pharmaceutical CMO is looking to hire an Associate Director of Quality Assurance to ensure compliant cGMP operations are maintained across the Burlington, MA site. The ideal candidate will be a strong leader and well versed in aseptic fill/finish and sterility assurance programs. 

The company takes pride in its organic growth, so career progression for this individual is open. This Associate Director reports to the Director of Quality and works closely with other departments and groups in order to maintain high levels of cGMP compliance in all activities.  

The Associate Director of Quality Assurance will have the following responsibilities:
  • Create and sustain a risk-based and scientific-based quality system.
  • Ensure all GMP operations are in compliance while preserving an effective workflow to aid operational excellence.
  • Deliver quality oversight and review the company’s validation program (process, cleaning, computer software, and instrument qualification)
  • Oversee the site quality assurance program (including training and auditing programs, review of SOPs, investigations, specifications, manufacturing records, etc…)
  • Release/rejection of GMP materials 

The ideal candidate will have the following skill set:
  • 8-10 years of QA and/or QC experience in drug substance and/or drug product manufacturing
  • Minimum of 3 years in management role
  • Minimum 5 years experience in aseptic fill/finish and sterility assurance
  • Bachelor’s degree in Microbiology, Chemistry, or related field; Advanced degree preferred
  • Strong knowledge of FDA regulations
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