This Hybrid role could be based in any of these AbbVie locations: North Chicago, IL Cambridge, MA,  Irvine, CA, San Francisco, CA

Purpose:
Primarily responsible for leading Product Development QA from an analytical perspective in
support of clinical supply release.

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
• impacting multifunctional areas
• Approve Laboratory investigations
• Responsible for assessing compliance to regulations and industry practice and
• implementing applicable process changes