Global QC Product Lead

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 AbbVies 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 AbbVies 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 AbbVies 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 :

• Bachelors degree with 16 years of relevant industry experience Masters 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 or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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. 

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No

Employment Type :

Full-time