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.

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