Sr. Manager, GCP Compliance

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases.

More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit  We have an excellent opportunity for a Sr. Manager, GCP Compliance to join our team. This position is a hybrid role with 2 days a week onsite in our San Diego, CA.

Office.

Responsible for managing the Quality Assurance Department’s GCP compliance projects and activities in compliance with Xencor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.

• Manages and maintains the QA GCP Compliance program including developing, implementing, and maintaining a system of quality to ensure clinical trial activities are performed; data are generated and documented in accordance with applicable regulations.
• Identifies and assesses risk areas and supports the development and implementation of risk mitigation measures
• Supports the development and implementation of audit plans and annual GCP audit strategy
• Performs audits of clinical investigator sites, clinical vendors and Xencor processes and systems for compliance with governing procedures
• Evaluates current quality systems, processes, procedures and protocols for compliance
• Supplements the development of internal SOPs, policies and procedures as required
• Escalates regulatory compliance risks to Quality and Clinical Leadership to ensure that all issues are mitigated in a timely manner
• Performs timely and effective follow up of quality issues, including those issues that result in the implementation of a Xencor Corrective and Preventative Action (CAPA) Plan
• Maintains up-to-date working knowledge of national and international standards and guidelines related to GCP
• Supports the understanding, communication and coordination of clinical quality / compliance initiatives and QA compliance standards to internal stakeholders
• Delivers GCP training across the organization as needed
• Guides Clinical Development on internal and external regulatory and quality audits
• Provides guidance and support to clinical study teams in the identification and investigation of potential serious GCP compliance issues at investigator sites and/or clinical trial vendors
• Works with Clinical to track and ensure external Clinical vendors are audited on an appropriate schedule
• Supports Xencor clinical trial teams to remain inspection-ready and compliant with internal processes, study protocols, ICH-GCP and applicable regulations
• Serves as a subject matter expert on GCP compliance related issues
• Adheres to all department and company-wide policies regarding conduct, performance and procedures

• Performs other duties as assigned.

Position requires a minimum of a bachelor's degree, plus at least 8 years of experience in clinical drug trial development, preferably within a pharmaceutical or biotech environment, CRO experience may be considered. Also requires 3 years’ auditing experience in clinical research, regulatory compliance, GCP and/or quality assurance environment. Experience in a global environment from a regulatory/GCP compliance perspective is also required.

• Ability to work independently with minimal supervision
• Strong computer skills including proficiency in use of Microsoft Outlook, Word, Excel and Power Point
• Strong knowledge of regulatory compliance and QA issues within a pharmaceutical, biotech or medical device organization
• Knowledge of current US FDA Regulations and ICH Guidelines governing clinical trials and recent global regulatory initiatives
• Ability to use written and verbal communication skills to…