Sr. Manager, GCP Compliance

Role Summary

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.

• 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
• 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
• Ability to work independently with minimal supervision
• Strong computer skills including proficiency in 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 communicate complex scientific, medical and program issues in written and verbal form
• Ability to partner with cross-functional teams from research, pre-clinical development, manufacturing, quality, regulatory and clinical development
• Flexibility and adaptability for the changing requirements and fast pace of a small biotechnology company
• Knowledge of MS Word, Excel, and PowerPoint; familiarity with relevant laws, regulations, and agency rules
• Strong foundational knowledge of ICH, GLP, cGMP requirements and GXP regulations
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model

• Bachelor's degree required; advanced degree preferred in a related field

• Occasional travel may be required, including travel between Pasadena and San Diego offices