Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have an excellent opportunity for an experienced Quality Assurance Senior Associate up to a Senior Manager to join our Quality Assurance team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eight in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies including Novartis, Amgen, MorphoSys, Merck, CSL, Janssen (J&J), Alexion and Boehringer Ingelheim.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
The successful candidate will be a well experienced, self-motivated Senior Associate/Manager who will manage the Quality Assurance Department’s GCP compliance projects and activities covering the Clinical Development area at Xencor. They will also be responsible for compliance with applicable Corporate and Divisional Policies and SOPs. This position can be located at either the Monrovia or San Diego facility with regular travel to the other site.
Job Duties include:
• Perform Quality audits of clinical investigator sites and clinical vendors
• Evaluate current quality systems, processes, procedures and protocols for compliance
• Supplement and develop internal SOPs, policies and procedures as required
• Draft Quality Agreements with Clinical Vendors
• Track, trend GCP Audit Metrics
• Provide GCP compliance metrics to Xencor management on a routine basis
• Escalate regulatory compliance risks to Quality and Clinical Leadership to ensure that all issues are mitigated in a timely manner.
• Maintain up-to-date working knowledge of national and international standards and guidelines related to GCP
• Promote understanding, communication and coordination of the clinical quality / compliance initiatives and QA compliance standards
• Work with the Clinical Department’s Compliance Manager to develop new hire on-boarding and GCP training, conduct GCP training within Xencor.
• Provide consultative support to Clinical Development for internal and external regulatory and quality audits
• Provide guidance and support to clinical study teams in the identification and investigation of potential serious GCP compliance issues at investigator sites.
• Work with Clinical to track and ensure external Clinical vendors are audited on an appropriate schedule
• Serve as a subject matter expert on GCP compliance related issues
• Approximately 20% travel (domestic and international) may be required
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Ability to work independently with minimal supervision
• Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
• Strong oral and written communication skills
• Strong knowledge of regulatory compliance and QA issues within a pharmaceutical, biotech or medical device organization
• Experience in a global environment from a regulatory/GCP compliance perspective
• Current knowledge of US FDA Regulations and ICH Guidelines governing clinical trials and recent global regulatory initiatives
• Minimum of 3+ years of experience in pharmaceutical, biotech or medical device development with regards to GCP compliance.
• Minimum of 2+ years of experience with project management, preferably in clinical research, regulatory compliance and/or quality responsibilities within a clinical operations organization
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume to email@example.com. For further information about Xencor, please visit our website at www.xencor.com EOE