Senior Manager, Quality Assurance - (Combination Products & Medical Devices)

📋 Description

• Lead quality function within Operations and oversee AbbVie Quality Systems implementation.
• Manage QA activities across plant operations including incoming QA, manufacturing QA, validation
• Supervise a team of quality professionals; set budgets and drive quality initiatives and compliance.
• Provide regulatory and technical guidance; act as SME for AbbVie plants; communicate with
• Ensure conformance to cGMP, FDA, EU, DEA and other regulatory requirements across plant operations.

🎯 Requirements

• Bachelor’s degree in Physical/Life Sciences, Pharmacy, or Engineering; advanced degree preferred.
• 8+ years in Manufacturing, QA, QC, R&D in pharma/biologics/devices; 4+ years supervisory
• Strong knowledge of statistical quality systems, electronic document management, and LIMS.
• Familiarity with regulatory requirements and excellent people management and communication skills.

🎁 Benefits

• Comprehensive benefits package including PTO, medical/dental/vision insurance.
• 401(k) plan and eligibility for long-term incentive programs.
• Equal opportunity employer; supportive of diversity and inclusion.