Quality Control Supervisor (FHX)

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

Qualifications :

• Bachelors 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.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time