Associate Director, Product Quality
Listed on 2026-10-06
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Quality Assurance - QA/QC
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Healthcare
Lead global Quality Assurance for pharmaceutical, biologics, and combination products, including sterile, biological, and device assets, ensuring compliance and on-time product delivery.
Responsibilities:oversee product transfer activities, develop and implement quality strategies supporting manufacturing at Abb Vie and third-party sites, act as primary QA contact for external manufacturing, support regulatory submissions, and manage quality metrics and compliance risk mitigation. Lead team activities related to audits, inspections, and quality systems development, including SOP and training implementation. Build relationships with external manufacturers, affiliates, and regulatory bodies to ensure quality standards.
Qualifications:Bachelor's in Life Sciences or related field; 10+ years in QA, regulatory, or operations within pharma, with direct experience interacting with regulatory agencies; strong knowledge of pharmaceutical and biologics technologies, manufacturing processes, and quality systems.
Preferred:graduate degree, plant experience, and expertise in biological/sterile products.
High-Value:extensive experience with third-party manufacturing, regulatory inspections, and global compliance; leadership in quality systems; cross-functional collaboration with R&D, Supply Chain, and Regulatory teams.
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