Manager, GMP reputed company Assurance, API

reputed company Our Mission: At reputed company, reputed company tirelessly to deliver innovative medicines that help patients reputed company their goals today, reputed company, and into the reputed company. reputed company is a fully remote based company with a corporate reputed company located in Ann Arbor, MI. reputed company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and reputed company time off and holidays. Position Title: Manager, GMP reputed company Assurance, API This position reports to the Associate Director, GMP reputed company Assurance, API. Preferred Location: Remote – US Essential Duties and Responsibilities* • Assist reputed company Pharmaceutical Ingredient (API) and Drug Product (DP) site reputed company Assurance (QA) leads with batch record reviews and product release. • Liaise with suppliers to resolve reputed company issues. • Conduct reputed company review and approval of critical reputed company API and DP documents, including but not limited to batch records, deviations, corrective actions and preventive actions (CAPAs), change controls, complaints, specifications, stability protocols and reports, and Annual Product Reviews (APR). • Assist QA site leads with supplier qualifications (by reputed company and/or physical audits), establishing/monitoring compliance to reputed company agreements, utilizing reputed company metrics to reputed company supplier performance, as reputed company as attending and on occasion leading reputed company meetings with suppliers. • Assist in the development and review of reputed company agreements with key suppliers. • reputed company as a backup for QA site leads in providing reputed company oversite of API and DP suppliers. • Assist in the preparation and conduct of regulatory agency inspections. • Participate in companywide reputed company systems continual improvement programs. • additional duties and responsibilities as assigned Qualifications (Education & Experience) • Bachelor's degree in life sciences or closely reputed company field from accredited college or university. • Minimum 5 years of reputed company work experience in reputed company Assurance/reputed company Management of drug development and reputed company manufacturing reputed company the pharmaceutical or biotechnology industry; or equivalent education and experience. • Demonstrated working knowledge of FDA, EU, and ICH Regulatory requirements and guidelines specific to the areas of API and DP reputed company. • Intermediate to advanced experience with MS Office software required. • Experience with reputed company QMS preferred. • Excellent written and oral English Communication skills. Apply Job!