Quality Assurance Manager

Quality Assurance Manager (Florham Park, NJ) – Analyze and oversee quality assurance of pharmaceutical product, including quality control practice, CMC (Chemistry, Manufacturing, and Control), and process in all stages of the drug manufacturing, testing, packaging, and documentation, and FDA drug approval submissions, to ensure product quality standards and FDA/ANDA regulatory compliance; Identify, mitigate, and resolve regulatory compliance and quality issues that may affect drug products; Perform batch records review and communicate any adverse findings to approved Contract Manufacturing Organizations (CMO); Perform product quality investigations and participate in the assessment of each investigation; Review investigation reports and complete the timely closure of all batch record review findings prior to product release; Resolve quality issues, and product complaints including investigations, deviations, OOS/OOT investigations, CAPAs, change controls, and quality complains related to manufacturing packaging; Implement CAPAs and assess CAPA effectiveness; Review and approve stability protocols and stability results; Review and Approve Validation (process, cleaning, method) protocols and reports, Author and review Annual Product Review, Draft and negotiate Quality and Technical Agreements; Provide support during regulatory inspections and audits, including Labeling development; Implement and maintain quality systems, including change control, vendor qualification programs, internal and external audits, SOPs, and process improvement. 

Must have a Master’s Degree in Chemistry, Pharmaceutics, or Drug Regulatory Affairs plus 1 year experience in job offered. Require skills and knowledge in Change Control, Validation, Audits, Investigation/CAPA, CMC, SOP/ANDA, batch records.

Job location: Florham Park, NJ. Standard benefits with $141,190.00~$144k/year. Submit résumé referencing job code MIS007 to HR, Shionogi, Inc., 400 Campus Drive, Florham Park, NJ 07932.

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Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

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