Senior QC Tech Services Lead – Global Investigations & CapEx

AbbVie Inc.; Barceloneta (PR); In loco; USD 121.000 - 237.000; Tempo pieno

Descrizione del lavoro

AbbVie Inc. is seeking a Sr Manager, Quality Control Technical Services to lead end-to-end QC operations, investigations, trend reporting, and capital projects. You will oversee shared services, QC IT, and NPI readiness, ensuring compliant laboratory operations and continuous supply.

Strong cGMP knowledge and people leadership are essential. The role requires 10+ years in pharma/biotech with QC experience, plus 5+ years managing direct reports.

Competenze

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or a related field; advanced degree preferred.

Mansioni

• Lead and provide end-to-end accountability for QC Technical Services functional areas (Investigation Reports, NCRs, Trend Reports, Shared Services, QC IT, NPI, TMTs, TMVs, capital projects).
• Establish priorities, governance, resource plans, KPIs, and escalation pathways for assigned areas to support compliant laboratory operations and supply continuity.
• Provide technical and compliance oversight for investigations and nonconformances; ensure timely, scientifically sound investigations with effective CAPAs.
• Own or oversee QC trending and performance reporting, including quarterly reports, data interpretation, and escalation of risks.
• Direct Shared Services activities including sample receipt, chain of custody, storage, movement, shipment, and lifecycle management.
• Provide business ownership for QC laboratory computerized systems; coordinate incident resolution, data integrity controls, changes, validation, continuity, and IT partnerships.
• Lead readiness for new product introductions and lifecycle changes; coordinate analytical deliverables, capacity assessments, method implementation, and cross-functional execution.
• Lead or oversee TMT and TMV strategies, protocols, execution, data evaluation, and acceptance criteria; ensure methods are fit for use and well documented.
• Lead QC capital projects and lab technology initiatives from needs to handover, including validation, change control, and vendor coordination.
• Develop organizational capability through coaching, training, performance management, succession planning, budget/resource stewardship, and audit readiness.

Conoscenze

Leadership

Data analysis

Change control

Quality systems

GxP knowledge

Project management

Lab operations

Regulatory compliance

Communication

Formazione

Bachelor's degree in Chemistry/Biology/Pharmacy/Engineering

Advanced degree preferred

Strumenti

LIMS/Sample Manager

Empower

LabX

TrackWise

SAP

Maximo

Power BI

Descrizione del lavoro

AbbVie Inc. is seeking a Sr Manager, Quality Control Technical Services to lead end-to-end QC operations, investigations, trend reporting, and capital projects. You will oversee shared services, QC IT, and NPI readiness, ensuring compliant laboratory operations and continuous supply.

Strong cGMP knowledge and people leadership are essential. The role requires 10+ years in pharma/biotech with QC experience, plus 5+ years managing direct reports.