To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02815

About our client Our client is a publicly traded biotechnology company headquartered in Los Angeles that focuses on the development and commercialization of various oncology therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director/Manager of Quality Assurance Los Angeles, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide quality assurance support (US and EU) for the company’s assigned development drug candidate(s) 2) Select sites for auditing 3) Handle the release of clinical trial material 4) Select audit members and inspections to ensure regulatory compliance 5) Plan and conduct GCP audits of sponsored clinical trials, CROs, clinical laboratories, internal processes, databases and clinical study reports (as necessary) 6) Provide (timely) written reports to inform the management of regulatory compliance status based on audits of CROs, investigator sites and internal audits of GxP processes 7) Assess and communicate compliance risk to the management 8) Oversee management of the company's quality system 9) Assist with the development, processing and maintenance of GxP policies (POL), SOPs and business practices 10) Assist with managing and resolving investigation question(s) from in-house and field CRAs as well as bringing closure to the question(s) 11) Participate in training on policies, SOPs, business practices and ICH-GxP regulations 12) Update and track all GxP audits 13) Perform QC reviews of regulatory documents in support of submission to regulatory authorities Requirements 1) BS in a technical discipline 2) Minimum 2 – 4 years of experience in the biopharmaceutical industry in at least 2 GxP areas 3) Experience in oncology preferred 4) Experience in auditing (clinical sites, CROs, clinical laboratories, clinical study reports and internal systems preferred) 5) Experience in and knowledge of GxP, ICH guidelines as well as Federal regulations and guidelines 6) Experience in reviewing Master Quality Agreements (MQA), clinical protocols, informed consents and laboratory data in a GxP environment 7) Experience in working in a document control system 8) Excellent communication skills (written and oral) 9) Proficiency in MS Office software applications 10) Willingness to travel – up to 25%