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QA Manufacturing Excellence Manager
Location:
Raritan, NJ
Description:
Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues. Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of manufacturing operations and technical activities Provide expertise and solutions to issues related to investigations and deviations occurring during routine manufacturing and protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations Assist in the development of process, operational, and quality improvements for manufacturing Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance with applicable Janssen standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions. Point of contact for technical and manufacturing operations for quality oversight Ability to work independently and successfully prioritize multiple tasks simultaneously Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous improvement Other duties may be assigned, as necessary. Requirements A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required A minimum of 9 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 9 years must include quality assurance experience. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus Strong knowledge of cell therapy process preferred Experience in cGMP regulatory body audits Strong interpersonal and written/oral communication skills Ability to quickly process complex information and make critical decisions with limited information Ability to work independently and be responsible for a portfolio of ongoing projects Ability to pay attention to details and follow procedures closely Ability to identify and assess possible gaps and work collaboratively to address such issues Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision Experience reviewing/auditing GMP documentation Strong proficiency with using Microsoft Office applications #LI-NP
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More About this Listing: QA Manufacturing Excellence Manager
QA Manufacturing Excellence Manager is a Quality Assurance QA Job at Legend Biotech USA located in Raritan NJ. Find other listings like QA Manufacturing Excellence Manager by searching Oodle for Quality Assurance QA Jobs.
QA Manufacturing Excellence Manager is a Quality Assurance QA Job at Legend Biotech USA located in Raritan NJ. Find other listings like QA Manufacturing Excellence Manager by searching Oodle for Quality Assurance QA Jobs.