Senior Manager, Quality Assurance

About the role

The Senior Manager, Quality Assurance will lead the Microbiology, Quality Systems, CAPA, audit, document control, DAL and DHR functions to ensure compliance, continuous improvement and risk mitigation across AbbVie’s manufacturing operations.

Key responsibilities

• Provide technical direction on microbiology applications and assess microbiological impact of process or product changes.
• Manage resources and drive improvement, cost‑reduction and risk‑reduction projects across all quality domains.
• Lead root‑cause investigations and implement corrective and preventive actions (CAPA).
• Plan, execute and oversee the internal audit program to meet regulatory requirements.
• Prepare for and support external audits and inspections of the plant quality system.
• Oversee the Corrective and Preventive Action system, DHR complaint investigations and DAL returned‑product analysis.
• Ensure the Document Center operates in compliance with applicable standards.

Required profile

• Bachelor’s degree in Engineering, Microbiology, Biotechnology or related field.
• Minimum 5 years of managerial experience in quality systems and at least 5 years leading microbiology teams in the medical industry (preferred).
• Experience with external and internal audits and with quality regulations for medical devices (ISO 13485:2016, FDA, EU MDR).
• Proven track record in continuous‑improvement projects and risk‑management methodologies.
• English proficiency at C1 level (spoken and written).

Required skills

• Microbiology
• Quality Management Systems
• CAPA (Corrective and Preventive Action)
• Internal and External Audits
• ISO 13485
• FDA regulatory compliance
• EU MDR compliance
• Risk Management
• Root‑Cause Analysis
• Continuous Improvement methodologies