Senior Manager, Quality Assurance

Job description

Summary The Senior Manager, Quality Assurance is responsible for leading and managing the Quality Assurance team and activities, management of the internal/external audit programs, Supplier Quality Management, Annual Product Review, Quality Agreements, management of the batch record pre and post review process, review of Validation Protocols and Reports, and resolution of customer quality issues. The Senior Manager is responsible for contact with QA internal and external customers regarding quality issues related to documentation, inspection, receiving, manufacturing/packaging and distribution processes. This role will serve as a subject matter expert and will ensure that their team is trained and operates compliantly with applicable SOPs, internal processes and regulations. Essential Duties and Responsibilities: -including providing oversight of master batch record issuance and batch release processes for Manufacturing and Packaging - Provide leadership, guidance and direction for the Quality Assurance team. - Oversee the key quality processes that impact/relate to product compliance including batch record review and product release, compliance in movement and storage of materials...