Within this role you will be responsible for all aspects of the assigned QA team providing leadership and support to direct reports and providing QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement.
As an Associate Manager/Manager QA (MES & Projects), a typical day may include, but is not limited to, the following: Leading all aspects of QA Team such as reviewing and approving the following types of documents, relating to area functions: master records, executed records, failure investigations, change control, SOPs, validation protocols and summary reports Approving various documents relating to area function including those listed above Coordinating QA resources assigning to functional area's to meet goals and timings; coordinating prioritization of activities with area management Performing compliance monitoring of operations, including trending of failures and evaluating efficiency of corrective actions Reviewing customer requirements and implementing required processes, as needed, to meet customer expectations regarding quality Participating in internal, regulatory and customer audits Identifying opportunities for improvement in the QA program and processes Leading the planning and execution of QA and projects with a focus on digital transformation, within regulatory guidelines, working closely with cross-functional teams, using excellent communication and project management skills Building and maintaining positive relationships with a wide variety of internal and external partners Ensuring teams and partners are aligned on project plan, plans and tracking project activities, providing contingency and risk mitigation planning for projects This role might be for you if: You have strong project management skills You are a dedicated leader that can develop growing teams You have the ability to identify continuous improvement needs You have an understanding of MES You have experience in understanding and interpreting regulatory guidelines and documents You have a strong Quality mindset To be considered for this opportunity you must have a Bachelor's degree in a Science/Quality/Engineering discipline or related field with minimum 7+ years of experience in pharmaceutical or biologics manufacturing environment.
Relevant experience may be considered in lieu of the educational requirement.
MES experience is advantageous.
Supervisory and/or leadership experience is essential.
Associate Manager: 7+ years of relevant experience / Manager: 8+ years of relevant experience.
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We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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