Associate Director, Product Quality
Core
Ensures quality, compliance, and on-time delivery of pharmaceuticals, biologics, devices, and combination products across global supply chains, including third-party manufacturing and new product launches.
Role type
Senior IC Associate Director, Product Quality
Builds
Global supply chain quality systems, regulatory submissions, and compliant product transfers for AbbVie and partners
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance & Compliance)
Required skills
Strategic leadership, regulatory inspection experience, cross-functional team management, risk assessment, contract negotiation, audit management, CAPA oversight, SOP development, stakeholder alignment
Preferred skills
Plant operations experience, biological/sterile product knowledge, multi-site coordination, crisis management
Technologies
GMP, FDA/EMA/MHRA regulatory frameworks, Quality Management Systems (QMS), Chemistry Manufacturing and Controls (CMC)
Responsibilities
Lead quality teams for product transfers and new launches; develop global quality assurance strategy; act as primary contact for third-party manufacturers and regulators; make key decisions on compliance and risk; manage legal supply agreements and technical contracts; oversee audit readiness and inspection responses; drive continuous improvement in quality systems.
Seniority
Senior, strategic leadership & hands-on management