Superviseur Contrôle Qualité (F/H/X)
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Martillac, Nouvelle-Aquitaine
- Opérations
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 www.abbvie.com. 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 escalate 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
- 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.
AbbVie est un employeur garantissant l'égalité des chances et s'engage à agir avec intégrité, à stimuler l'innovation, à transformer des vies et à servir notre communauté. Employeur garantissant l'égalité des chances pour les anciens combattants et les personnes en situation de handicap.
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