Associate Director R&D QA

Boston, MA 02111

Posted: 08/04/2021 Employment Type: Direct Hire Job Title: QA - Automated Job Number: 8865

Job Description


Our client is looking to immediately place  a Manager of R&D QA; Pharma Experience is Required. 
  • Support  the Quality Assurance, Quality Control, and Analytical Services Divisions. 
  • Ensure compliant phase appropriate cGMP operations are continuously maintained across the site leading up to project turnover to commercial production.
  • Support a partnership with the Quality unit charged with the review and management of departure investigations (i.e., root cause analysis, product impact assessments, and CAPA), GMP document review, on-floor batch review, batch disposition, and also supporting phase appropriate quality oversight during technology transfer.
  • Play a vital role during regulatory agency inspections and client audits as pertaining to R&D/clinical products and processes. 
  • Establish and maintain a risk-based and scientific-based phase appropriate quality system to protect the public health and to meet business needs.
  • Oversee, and be ultimately responsible for, the R&D business unit’ s quality assurance program. This includes overseeing and assisting with the Company’ s training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation/ verification reports, analytical reports, and manufacturing records

MUST HAVE:
  • Must have a Bachelor’ s Degree in Life Sciences or related field
  • Must have 8+ years of experience in the Pharmaceutical industry, with at least 5 of those years being experience in Quality.
  • Must have experience in aseptic fill/ finish and sterility assurance programs.
  • Must have experience in clinical quality assurance
  • Must have Solid knowledge in FDA and global regulations, especially the cGMP for the 21st century initiatives

 

 

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Jennifer Harris

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