Sr Manager, Quality Control Technical Services

About the role

AbbVie is hiring a Senior Manager for Quality Control Technical Services. The role leads one or more QC technical service functional areas and provides end-to-end accountability, ensuring compliant laboratory operations and continuity of supply. It is a full-time position.

Key responsibilities

• Lead QC Investigations (LIRs and NCRs), Trend Reports (Quarterly Reports, Track & Trend), Shared Services (sample management and laboratory services), QC IT Support, QC NPI, TMTs, TMVs and QC Capital Projects, including equipment qualifications and new technology implementation.
• Set priorities, objectives, governance, resource plans, performance indicators and escalation pathways for assigned areas, and turn site, Quality and business strategy into tactical deliverables.
• Provide technical and compliance oversight of laboratory investigations and nonconformances, backed by CAPAs and recurrence prevention.
• Own or oversee QC trending and performance reporting, including periodic and quarterly reports, Track & Trend activities and escalation of quality or business risks.
• Direct Shared Services activities such as sample receipt, chain of custody, storage, movement, shipment, reconciliation and lifecycle management.
• Support QC laboratory computerized systems and digital solutions, including incident resolution, data integrity controls, system changes, validation deliverables and business continuity.
• Lead QC readiness for new product introductions and lifecycle changes, coordinating with Manufacturing, MS&T, Regulatory, Supply Chain, Engineering and Quality.
• Lead or oversee TMT and TMV strategies, protocols, troubleshooting, acceptance criteria and reports.
• Lead QC capital projects and lab technology initiatives from business need through operational handover.
• Build team capability through coaching, training, performance management and succession planning, and maintain audit and inspection readiness.

Required profile

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering or another relevant scientific or technical discipline; an advanced degree is preferred.
• Minimum 10 years of progressive experience in the pharmaceutical, biotechnology, medical device or other regulated industry, with significant experience in Quality Control, laboratory operations, technical services, quality systems or validation.
• 5+ years of experience managing direct reports and leading technical professionals and cross-functional teams.
• Demonstrated project and program management capability for medium to large initiatives.
• Bilingual English and Spanish, written and verbal.

Required skills

• Strong knowledge of cGMP, laboratory controls, data integrity, quality risk management, deviation/investigation and CAPA systems, change control and inspection readiness.
• Experience in one or more of: laboratory investigations and NCRs, statistical trending and periodic reporting, sample management, laboratory computerized systems, NPI, TMT/TMV, equipment qualification, capital projects or lab technology implementation.
• Ability to evaluate laboratory data, protocols, qualification/validation packages and GMP documentation.
• Familiarity with LIMS/Sample Manager, Empower, LabX, Track Wise, SAP, Maximo, electronic validation platforms, Power BI or comparable applications is preferred.

What we offer

• Paid time off (vacation, holidays, sick leave).
• Medical, dental and vision insurance and 401(k) for eligible employees.
• Eligibility for long-term incentive programs.