Associate Director, Product Quality
Core
Lead global product quality strategy and operations for pharmaceuticals, biologics, devices, and combination products across AbbVie plants and third-party manufacturers to ensure on-time delivery and regulatory compliance.
Role type
Senior Director-level Product Quality Assurance Manager
Builds
Global supply chain quality systems, regulatory submissions, and third-party manufacturing agreements
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Assurance Operations Management, Regulatory inspection experience, Third-party manufacturer management, Strategic program leadership, SOP development and maintenance, Cross-functional team leadership, Risk management, Technical problem solving, Legal supply agreement negotiation, Audit and inspection readiness
Preferred skills
Graduate degree in Life Science, Direct plant experience in pharmaceutical setting, Knowledge of biological/pharmaceutical technologies (sterile, liquid, solids, devices), Experience with FDA/EMA/MHRA interactions
Technologies
Chemistry, Manufacturing, and Controls (CMC) documentation, Drug Master files, Certificate of Suitability, CAPA systems, Regulatory filing systems
Responsibilities
Lead team for product transfer activities and new product launches; Develop and implement global Product Quality Assurance strategy; Act as primary quality contact for third-party manufacturers and regulatory bodies; Make key decisions on product quality and compliance issues; Manage legal supply agreements and technical agreements; Establish relationships with external quality organizations; Manage audit plans and inspection readiness; Lead strategic programs including site selection and continuous improvement.
Seniority
Senior, strategic leadership with hands-on operational oversight