What are the responsibilities and job description for the Quality Assurance Manager position at Ambio, Inc.?
Company Description
Ambio is a specialty pharmaceutical company developing biosimilar, bioequivalent, and other complex generic drugs. Ambio has built a robust pipeline, executed partnerships with leading pharmaceutical companies, and established proprietary know-how and technological advances in peptide drug development and manufacturing. Starting in 2024, Ambio’s advanced pipeline will deliver commercial launches of several biosimilar drugs targeting blockbuster indications over the next few years. Furthermore, we are developing more complex drugs biosimilar to existing biologics and peptide drugs in the therapeutic areas of diabetes, obesity, and beyond..
Role Description
This is a full-time, on-site role for a Quality Assurance Manager located in Grovetown, GA. The Quality Assurance Manager will oversee the development, implementation, and monitoring of quality assurance systems and processes. Responsibilities include ensuring compliance with industry regulations, conducting quality audits, managing risk assessments, and addressing quality-related issues. The role also involves leading continuous improvement initiatives, overseeing documentation, and collaborating with cross-functional teams to maintain product quality and operational standards. The role actively participates in all the FDA related PAI preparation onsite and at the CMOs/CDMOs as required.
Qualifications
- Fundamental knowledge of drug product compliance principles
- 5 years experience in the pharmaceutical industry, in a QA role
- Experience in quality assurance processes, compliance monitoring, and quality audits
- Proficient in the use of Microsoft (Access, Excel, Word)
- Proficiency in quality documentation and reporting