Manager, Quality Assurance

About the role

The Manager, Quality Assurance will provide technical direction and support for microbiology activities within AbbVie’s manufacturing environment. This role ensures that microbiological assessments are performed for any changes affecting processes or products, and leads continuous‑improvement, cost‑reduction and risk‑mitigation projects.

Key responsibilities

• Guide microbiology applications and ensure appropriate assessments for manufacturing changes.
• Manage resources and capabilities across functional areas, coordinating improvement and risk‑reduction initiatives.
• Lead root‑cause investigations and drive corrective and preventive action (CAPA) implementation.
• Oversee the Internal Audit System to meet regulatory requirements.
• Prepare for and support external audits and inspections of the plant Quality System.
• Administer the facility’s CAPA system and supervise complaint investigations (DHR) and returned product analysis (DAL).
• Ensure compliance of the Document Center and related standards.

Required profile

• Bachelor’s degree in Engineering, Microbiology, Biotechnology or a related field.
• Relevant certifications such as Risk Management, Green Belt, Certified Quality Engineer (CQE) or CMQ‑OE preferred.
• English proficiency at C1 level (spoken and written).

Required skills

• Microbiology
• Quality Assurance
• Internal and external auditing
• CAPA management
• Root‑cause investigation
• Risk management
• Green Belt methodology
• CQE or CMQ‑OE certification