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QA Consultant - Ophthalmology
Job Opportunity at
MEIRxRS / Med Exec Intl
Posted on May 16
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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