Global QC Product Lead

AbbVie; North Chicago (IL); Vor Ort; USD 142.000 - 269.000; Vollzeit

Zusammenfassung

AbbVie Inc. is seeking a Global QC Product Lead to drive analytical strategy across the QC network. You will oversee method validation, transfer, and lifecycle readiness, partnering with R&D, PDS&T, and regulatory teams to ensure compliant, scalable QC solutions.

This leadership role emphasizes risk-based decisions and cross-site coordination. You will mentor scientists, align platforms, and champion standardization to enable reliable commercial execution and robust quality control across

Qualifikationen

• 16+ years of experience in analytical chemistry or related field.
• Leadership in analytical development, QC, validation, or transfer.
• Knowledge of GMP, data integrity, and regulatory expectations.

Aufgaben

• Lead global QC analytical implementation and lifecycle strategy for late-stage and commercial products.
• Represent Global QC in cross-functional product, CMC, analytical and transfer discussions.
• Translate development strategies into robust, compliant QC approaches for routine use.
• Review validation, co-validation, and method transfer strategies from a QC perspective.
• Mentor QC scientists and communicate complex issues to leadership.
• Identify risks and craft mitigation plans across sites and functions.

Kenntnisse

Analytical leadership

Cross-functional collaboration

Quality governance

Risk assessment

Ausbildung

Bachelor’s degree with 16+ years of relevant industry experience

Master’s degree with 14+ years of relevant industry experience

PhD with 8+ years of relevant industry experience

Jobbeschreibung

• Compensation: USD 141,500 - USD 268,500 - yearly

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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.
• Comprehensive knowledge of the analytical method lifecycle and the 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 the ability to present recommendations, risks, decisions, and mitigation plans to technical and leadership audiences.

Preferred Qualifications

• 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.