Sr Manager, Quality Control Technical Services (Vilafranca del Penedès)

Sr Manager, Quality Control Technical Services (Vilafranca del Penedès)

02 nov
|
Abbvie
|
Vilafranca del Penedès

02 nov

Abbvie

Vilafranca del Penedès

Company Description
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 Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Lead and provide end-to-end accountability for one or more QC Technical Services functional areas: QC Investigations (including Laboratory Investigation Reports [LIRs] and Nonconformance Reports [NCRs]); Shared Services (including sample management and laboratory services); QC IT Support; QC NPI; and QC Capital Projects, including equipment qualifications and new technology implementation.
Establish priorities, objectives, governance, resource plans, performance indicators, and escalation pathways for assigned functional areas. Translate site, Quality, and business strategies into tactical deliverables that support compliant laboratory operations and continuity of supply.
Ensure investigations are scientifically sound, appropriately documented, completed within established timelines, and supported by effective corrections, corrective and preventive actions (CAPAs), and recurrence-prevention measures.
Own or oversee QC trending and performance reporting processes, including periodic and quarterly reports, Track & Trend activities, data interpretation, identification of adverse or recurring trends, and escalation of significant quality or business risks to the appropriate leadership and governance forums.
Direct Shared Services activities, as assigned, including sample receipt, chain of custody, storage, movement, shipment, reconciliation, and lifecycle management, as well as laboratory service activities required to maintain safe, compliant, efficient, and inspection-ready QC operations.
Provide business ownership and functional support for QC laboratory computerized systems and digital solutions. Coordinate incident resolution, access and lifecycle activities, data integrity controls,



system changes, validation deliverables, business continuity, and partnerships with BTS/IT, Quality, vendors, and system owners.
Coordinate analytical deliverables, laboratory capacity and capability assessments, material and reference standard readiness, method implementation, training, documentation, and cross-functional execution with Manufacturing, MS&T;, Regulatory, Supply Chain, Engineering, and Quality.
Lead or oversee TMT and TMV strategies, protocols, execution, troubleshooting, data evaluation, acceptance criteria, reports, and implementation. Ensure transferred or verified methods are fit for intended use and supported by appropriate scientific rationale, documentation, training, and change control.
Lead QC capital projects and laboratory technology initiatives from business need through operational handover. Responsibilities may include user requirements, risk assessments, vendor coordination, commissioning, qualification/validation planning and execution, change control, computerized system validation, procedural updates, training, obsolescence management, and implementation of new technologies with minimal disruption to routine operations.
Build and sustain organizational capability through effective selection, coaching, development, training, performance management, succession planning, budget/resource stewardship, and cross-functional leadership. Maintain audit and inspection readiness and represent QC Technical Services during internal audits, regulatory inspections, management reviews, and project governance meetings.
Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering,



or another relevant scientific or technical discipline. 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.
~Strong knowledge of cGMP requirements, laboratory controls, data integrity, quality risk management, deviation/investigation and CAPA systems, change control, and inspection readiness.
~ sample management or laboratory support services; capital projects; Ability to evaluate laboratory data, technical protocols, qualification/validation packages, investigation reports, trend reports, and other GMP documentation using sound scientific and compliance judgment.
~ Demonstrated project and program management capability, including scope, schedule, budget, risk, vendor, dependency, and stakeholder management for medium to large initiatives.
~ Familiarity with systems such as LIMS/Sample Manager, Empower, LabX, Track Wise, SAP, Maximo, electronic validation platforms, Power BI, or comparable applications is preferred.
~ Strong written and verbal communication, technical writing, problem-solving, decision-making, negotiation, and influencing skills, with the ability to communicate effectively across all organizational levels and with external partners or regulatory agencies.
~ Bilingual proficiency in English and Spanish, written and verbal, is required.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
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.

📌 Sr Manager, Quality Control Technical Services (Vilafranca del Penedès)
🏢 Abbvie
📍 Vilafranca del Penedès

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