Product Quality Senior Manager

Role: Senior Quality Assurance Lead overseeing product quality for pharmaceuticals, biologics, and combination products at AbbVie, ensuring compliance, on-time delivery, and regulatory adherence. Responsibilities: manage quality aspects of product transfers, develop and implement global QA strategies, perform final release of manufactured lots, and lead risk assessments and issue resolutions related to sterile, biological, and device products. Establish and maintain external and internal quality relationships, support audits and inspection readiness, and contribute to new product launches and compliance activities. Requirements: Bachelor's in Life Sciences, Engineering, or related field; 8+ years of experience including 3+ years in QA operations management; strong background in pharmaceutical manufacturing, quality control, and regulatory inspections, with knowledge of biological/pharmaceutical technologies. Preferred: direct manufacturing experience, familiarity with FDA and international regulations, and experience with third-party manufacturing. HighValue: expertise in sterile, biological, and device products; global regulatory strategy development; audit and inspection management; experience supporting biologics and combination products across development and manufacturing stages.