Senior Manager, Product Quality Neurotoxin
Core
Ensure quality of assigned products and near-commercial neurotoxin pipeline products to meet business objectives and regulatory compliance worldwide.
Role type
Senior Manager, Product Quality
Builds
Regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products
Domain
Pharmaceutical manufacturing (Neurotoxin/Immunology/Oncology)
Required skills
Quality Assurance Operations Management, Regulatory inspection experience, Pharmaceutical manufacturing operations, Global change control management, Customer complaint management, Strategic program leadership, Technical/Analytical problem resolution, Contract alignment
Preferred skills
Direct plant experience in pharmaceutical setting, Knowledge of biological and/or pharmaceuticals
Technologies
Quality System Management records, CAPA, gCRB
Responsibilities
Direct cross-functional team to achieve on-time quality deliverables; Manage end-to-end customer complaints and routine trending; Oversee global change control system and chair gCRB; Develop and implement global Product Quality Assurance strategies; Review and approve Quality System Management records; Make key decisions on product quality and compliance issues; Ensure alignment of Quality and Technical Agreements with legal contracts; Lead strategic programs including Brand Teams and Product Transfers.
Seniority
Senior, hands-on IC
