Global QC Product Lead
About The Position
AbbVie’s Global Lab Solutions (GLS), part of Operations Quality Assurance, designs and enables systems, capabilities, standards, and partnerships that strengthen laboratory performance and support consistent, compliant execution across its global Quality Control network. Global QC Product Governance connects R&D, Product Development Science & Technology (PDS&T), Operations Quality, and QC laboratories to translate product and analytical strategy into QC readiness. The Global QC Product Lead provides strategic Quality leadership and governance for implementation and lifecycle management of commercial analytical methods across AbbVie’s global QC network. As a primary Global QC interface for assigned products, the role integrates scientific, Quality, operational, and product considerations to ensure analytical strategies are compliant, suitable for routine use, transferable, and sustainable. The role provides independent oversight and decision-making for QC analytical implementation, including reviewing and challenging validation, co-validation, and method transfer strategies; assessing laboratory capability and readiness; and determining QC method designs for dependable commercial execution. The role requires analytical lifecycle expertise, enterprise thinking, risk-based judgment, and the ability to lead across a global matrix without direct authority. It helps protect testing continuity and product supply, support commercial readiness, accelerate pipeline transitions into the QC network, and build analytical capabilities that can be leveraged across products and laboratories.
Requirements
- Bachelor’s degree with 16+ years, Master’s degree with 14+ years, 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.
- Comprehensive knowledge of the analytical method lifecycle and transition of methods from development into sustainable commercial QC execution.
- Strong knowledge of current Good Manufacturing Practice requirements, laboratory controls, data integrity principles, and regulatory expectations applicable to pharmaceutical QC.
- Demonstrated ability to solve complex scientific and operational problems and make timely, defensible, risk-based decisions.
- Demonstrated success leading complex cross-functional initiatives and influencing outcomes across a matrixed, global organization.
- Strong stakeholder management, organizational, and communication skills, including presenting recommendations, risks, decisions, and mitigation plans to technical and leadership audiences.
Nice To Haves
- Broad experience across both analytical development and commercial QC environments.
- Experience with multiple analytical technologies, modalities, product types, and/or global QC laboratories.
- Experience supporting regulatory submissions, health-authority responses, regulatory inspections, or analytical-method-related commitments.
- Demonstrated experience with complex analytical method validation, transfer, investigations, remediation, and lifecycle management.
- Experience establishing platform approaches, global standards, technical governance models, or laboratory capability strategies.
- Demonstrated scientific leadership through mentoring, capability building, knowledge sharing, and continuous improvement.
Responsibilities
- Lead 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 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 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.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
