Director, Manufacturing QA
Core
Lead global quality assurance for AbbVie products (pharmaceuticals, biologics, devices) ensuring compliance with worldwide regulations and managing third-party manufacturer relationships.
Role type
Director, Manufacturing QA
Builds
Global quality systems, regulatory strategies, and supply chain quality agreements for new product introductions and transfers.
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global quality strategy development, third-party manufacturer management, regulatory inspection coordination, contract negotiation, audit planning, cross-functional leadership, risk management, validation oversight, compliance enforcement
Preferred skills
Graduate degree in Life Science/Pharmacy/Engineering, experience with sterile/biological products, cultural adaptability
Technologies
GMP, FDA/EMA/MHRA regulatory frameworks, quality management systems
Responsibilities
Lead product quality assurance transfer activities and end-to-end quality for assigned products; Ensure delivery of quality elements for new product launches involving third-party manufacturers; Make primary decisions on product quality, compliance, and regulatory conformance issues; Develop and implement global Product Quality Assurance strategy; Support development of legal supply agreements and quality/technical contracts; Function as main Quality liaison between Third Party Manufacturers and AbbVie Operations; Provide support for quality audits, initial site approvals, and due diligence activities; Negotiate with external companies to balance quality expectations with operational costs.
Seniority
Director, strategic leadership & team management