2018-05-16

QA Consultant - Ophthalmology
Job Opportunity at MEIRxRS / Med Exec Intl

Posted on May 16

https://meirxrs.com    818-247-1368

Location: San Clemente, CA
Job Type: Contract
Job ID: W4159690

Our client is about to begin enrolling the Phase III pivotal trials for their breakthrough drug/device combo. The client needs a senior QA consultant with pharma experience.  Ideally can come into their offices in San Clemente 2-3 days per week for the next 3-6 months.  Below is a wish list of experience/skills this person would have.
  • Leadership experience with cGMP manufacturing quality function for all clinical stages of development (Phase 1-3) and commercial product  
  • Sr. Director level, at least 5 years in similar role and demonstrated experience on specific projects for each stage of development covered above
  • Generate and ensure regulatory processes for clinical trial materials then build and establish company quality systems and facilities for global supply.
  • Experience writing and managing the development of drug cGMP SOPs
  • Experience in leading QC and QA personnel function for pharmaceutical and/or combination drug substances and products, including sterile drug products
  • Demonstrated experience in leading quality organization oversight of drug substance and drug product manufacturing including internal sites and external CMO's.
  • Key member of product CMC development teams for drugs including API,  Drug Substance, sterile solutions, and drug delivery systems, combination devices.
  • Leads teams in establishing and implementing key quality processes for product development, supplier quality management, and manufacturing including development and life-cycle management.
  • Experience with regulatory submission and CMC specific meetings (EoP2, Type C CMC meetings) with the regulatory agencies
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