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Associate Director of Quality Assurance (GMP)

Posted 24 days ago

Responsibilities for Associate Director of Quality Assurance:

QA management and oversight of Contract Manufacturing Organizations (CMO)

  • Master Batch Record Reviews and Executed Batch Record Reviews and Approvals; quality issue resolution, and batch disposition/release

  • Review and disposition of biologics drug/CMC intermediates, drug substance and drug product batches

  • Ensure product meets all in process and release specifications

  • Review any shipping excursions and ensure deviations are generated and material quarantined appropriately in the event of an excursion or other quality issue

  • Responsible in full for adherence with the quality agreement provisions

  • Ensure GMP compliance profile is maintained

  • Provide Quality metrics for process monitoring and annual product quality reports

  • Lead and/or support material review board meetings

  • Interface with CMO on regulatory inspections

Global Labelling and Supply Chain Operations support

  • Review and approve packaging and labelling master and production batch records

  • Review Vendor and prepare internal documentation such as deviations, NCMRs, OOS’, Investigations, CAPAs and effectiveness checks

  • Prepare documentation for Material Review Board presentation and meetings

  • Manage change controls for material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements

  • Perform vendor site visits and vendor audits to ensure components, raw materials, starting materials, and third-party facilities are fit for the intended function

  • Provide QA support for specification development and other as needed

Requirements:

  • Bachelor’s Degree or higher in a science or related field

  • 8+ years of direct Quality Assurance Experience working with Biologics with increasing responsibilities and GMP knowledge

  • Advanced working knowledge of 21 CFR 201/211, 600s requirements; international drug and biologics regulations/standards/guidelines a plus

  • Development to Commercialization Experience

  • Batch review and lot release, with Person-In-Plant oversight

  • Willingness to travel 10 % including international travel, but at times may be higher based on business needs