Job ID: #7390

QA Manager (GMP)

Cambridge, MA
Science Science
Management / Directors

 

Responsibilities of the QA Manager (GMP):

  • Responsible for the review and approval of quality documentation including quality agreements, project protocols, validation plans, batch records and associated data related to the manufacture and characterization of drug substances and drug products.
  • Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition.
  • Review pertinent CMC sections of regulatory submissions.
  • Contribute to preparation and review of regulatory filings.
  • Demonstrate strong leadership skills and experience working with all levels of management.

Requirements of the QA Manager (GMP):

  • BS in scientific discipline or related field and a minimum of 5 years relevant experience.
  • Must have experience providing QA support and oversight of GMP manufacturing operations.
  • Strong knowledge of cGMP regulations in relation to pharmaceutical product development, manufacturing and clinical operations.
  • Experience working with CMOs preferred.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
Commonwealth Sciences, Inc.
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Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.