AbbVie Laboratory Manager, Product Development QA at AbbVie leads analytical QA activities supporting clinical supply release. Responsible for managing the Lab QA team and driving continuous process improvements.
Responsibilities
Support CMC teams in resolving complex technical Analytical challenges through various phases
of development
Provide leadership and daily support to the Lab QA team
Drive continuous process improvement within Product Development QA by
updating/authoring policies/processes/procedures and related documents
Lead QA Analytical audit /inspection preparation activities and support the
audits/inspections as the QA SME
Develop, maintain, and report key quality metrics to Management
Lead for analytical testing batch release; coordination and issue resolution
Review and approval of excipient, drug substance and product specifications, including
justification and revisions
Write/review/approve exception reports, including high impact and complex ERs
Qualification
Required
Bachelor's degree or equivalent experience in life sciences or engineering
6-8 years of experience in quality assurance and/or analytical sciences
Strong understanding of API and drug product GMP manufacturing
Strong understanding of US and international quality systems regulations
