Quality Assurance Manager

Quality Assurance Manager

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. Standard benefits with $141,190.00~$144k / year.