Located in King of Prussia, Trevena is a publicly-traded, clinical-stage biopharmaceutical company dedicated to the discovery and development of groundbreaking new medicines. Established in late 2007, Trevena was created to translate Nobel Prize-winning research on GPCR signaling into a new generation of medicines: biased ligands.
This position manages the requirements of the quality management system, including implementation of cGMP document management systems and vendor management for active pharmaceutical ingredients and drug products. He/she collaborates with the technology department to plan and schedule cGMP compliance programs for the product development and lifecycle approach to validation. He/she reviews, approves, implements, and maintains CMC documentation including specifications, analytical methods, batch records, change controls, and investigations in compliance with cGMP, Trevena SOPs, and quality agreements.
The ideal candidate will possess a bachelor’s degree in life sciences or a related field. He/she will have a minimum of five years of manufacturing, quality control, or quality assurance experience in the pharmaceutical industry. The person will have working knowledge of the drug development process, ICH guidelines, FDA/international regulations, phase appropriate compliance, and FDA approval processes.
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