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Superviseur Contrôle Qualité (F/H/X)

MARTILLAC, 33
il y a 5 jours

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Position Summary The QC Supervisor is responsible for leading and coordinating expert-level quality control activities supporting drug substance testing readiness and release, including method validation and QC analytical test approval, QC subcontracted testing oversight, stability report completion, and OOS/OOT investigation management. This role ensures all activities are executed in compliance with applicable cGMP requirements, internal procedures, data integrity standards, and agreed drug substance release timelines.

Key Responsibilities

  • Supervise expert-level quality control activities.
  • Review, approve, and oversee method validation, drug substance and stability analytical test results in accordance with established procedures and quality standards.
  • Manage follow-up of subcontracted testing activities, including coordination with external laboratories, tracking deliverables, and ensuring timely closure of related actions.
  • Ensure timely completion, review, and approval of stability reports in line with study schedules, regulatory expectations, and program commitments.
  • Lead and coordinate OOS/OOT investigations, including root cause assessment, documentation, corrective and preventive actions, and cross-functional follow‑up.
  • Monitor QC workflows to ensure alignment with DS release agreed timelines and proactively elevate risks to schedule or compliance.
  • Collaborate with QC operation teams, Manufacturing, QA, MS&T, Regulatory, and Supply Chain partners to support release readiness and issue resolution.
  • Ensure all testing, investigations, and documentation are completed accurately, thoroughly, and on time.
  • Contribute with the team to QC transversal continuous improvement initiatives focused on efficiency, compliance, and laboratory performance.
  • Coach and develop team members, promoting technical excellence, accountability, and compliance culture.
  • Lead and/or coordinate QC global SOP series updates and implementations in the department

Qualifications

  • Bachelor’s degree in biology, chemistry, biotechnology or related scientific discipline.
  • Significant experience in QC laboratory operations within a pharmaceutical or biotech environment.
  • Strong knowledge of cGMP, analytical testing, stability programs, and OOS/OOT investigation processes.
  • Experience managing external laboratories or subcontracted analytical testing.
  • Fluency in English and French
  • Proven ability to prioritize and manage multiple deliverables against tight timelines.
  • Leadership, communication, documentation, prioritization and problem‑solving skills.
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Entreprise
AbbVie
Plateforme de publication
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