Lead the global QC analytical implementation and lifecycle strategy for assigned late-stage and commercial products.

Represent Global QC as a key Quality and scientific decision-maker in cross-functional product, CMC, analytical, validation, and transfer discussions.

Translate development analytical strategies into robust, compliant, and sustainable approaches for routine QC execution.

Provide strategic QC input from late-stage development through validation, co-validation, transfer, commercialization, troubleshooting, and ongoing lifecycle management.

Independently review, challenge, and approve proposed validation, co-validation, and analytical method transfer strategies from a QC implementation perspective.

Determine the final QC method design by balancing scientific requirements, product and regulatory needs, laboratory controls, network capability, and long-term sustainability.

Assess receiving-site readiness, including technical expertise, instrumentation, laboratory controls, capacity, documentation, and operational constraints.

Partner with QC sites and technical teams to identify and mitigate barriers to successful method implementation and reliable routine execution.

Lead alignment across R&D, PDS&T, QC Operations, Operations Quality Assurance, Regulatory Affairs, CMC, and product teams.

Provide scientific and Quality leadership for complex method transfer challenges, validation investigations, analytical issues, and cross-site troubleshooting.

Identify and communicate scientific, Quality, regulatory, operational, supply, and timeline risks, including clear recommendations, trade-offs, mitigations, and escalation plans.

Drive harmonization, platform approaches, reusable standards, lessons learned, and best practices that strengthen Global QC capability.

Global QC Product Lead

Responsibilities

Qualification

Preferred

Benefits

Company

AbbVie

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