Global QC Product Lead

Job Description

Global Lab Solutions (GLS), part of Operations Quality Assurance, designs and enables the systems, capabilities, standards, and partnerships that strengthen laboratory performance, support pipeline progression, and promote consistent, compliant execution across AbbVie’s global Quality Control network. Within GLS, Global QC Product Governance translates product and analytical strategy into QC readiness by connecting R&D, Product Development Science & Technology (PDS&T), Operations Quality, and QC laboratories to ensure analytical methods, standards, critical reagents, and supporting controls are ready for reliable commercial execution. AbbVie is seeking an accomplished scientific and Quality leader for the role of Global QC Product Lead. This individual will provide strategic Quality leadership and governance for the implementation and lifecycle management of commercial analytical methods across AbbVie’s global QC network. Serving as a primary Global QC interface for assigned products, the Product Lead will integrate scientific, Quality, operational, and product considerations to enable analytical strategies that are compliant, fit for routine use, transferable, and sustainable.

The role provides independent oversight and decision-making for QC analytical implementation, including review and challenge of validation, co-validation, and method transfer strategies; assessment of laboratory capability and readiness; and determination of the QC method design needed for dependable commercial execution. Success requires deep analytical lifecycle expertise, enterprise thinking, strong risk-based judgment, and the ability to lead across a global matrix without direct authority.

Key Responsibilities

• 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.
• Mentor QC scientists and technical subject matter experts and communicate complex technical matters clearly to project teams and senior leadership.

Why This Role Matters

The Global QC Product Lead helps ensure that AbbVie’s analytical methods can be executed reliably where and when they are needed. The role strengthens commercial readiness, protects testing continuity and product supply, accelerates pipeline transitions into the QC network, and builds durable analytical capabilities that can be leveraged across products and laboratories.

Key Interfaces

R&D and BioARD analytical leaders; PDS&T analytical and commercial method leads; QC site management, scientists, and technical subject matter experts; Operations Quality Assurance; Regulatory Affairs; Manufacturing; CMC and product teams; and other Quality and technical functions supporting assigned products.

Qualifications

• Bachelor’s degree with 16+ years of relevant industry experience, Master’s degree with 14+ years of relevant industry experience, or PhD with 8+ years of relevant industry experience in analytical chemistry, biochemistry, biological sciences, pharmaceutical sciences, chemistry, chemical engineering, pharmaceutics, or a related scientific discipline.
• Progressive scientific and Quality leadership experience in analytical development, Quality Control, analytical method validation, co-validation, method transfer, commercial analytical support, or related pharmaceutical or biopharmaceutical areas.

…