Quality Control Supervisor (F/H/X)
ExternalFull-timeOn-site1mo ago30+ days old, may be filled
ComplianceDocumentationHTMLLeadership
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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 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www.abbvie.com/join-us/reasonable-accommodations.html
Additional Information
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.
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