Manager, Quality Assurance Stability

Role Summary

Responsible for leading the development, implementation, and maintenance of Xencor’s Stability Program to ensure the safety, efficacy, and quality of clinical products. This role partners with CMC-analytical, manufacturing, quality, regulatory, and clinical teams to support stability activities across the product lifecycle. The position is hybrid with two days on-site per week in Pasadena, CA.

Responsibilities

• Owns and governs product-specific stability process from study design through reporting and lifecycle management
• Defines phase-appropriate, risk-based stability strategies aligned with development stage and business priorities
• Owns stability-related SOPs and templates (lean and fit-for-purpose)
• Acts as liaison with the CMC-analytical team to provide oversight of the stability protocols and data at the contract manufacturing/testing organizations in support of Xencor’s stability program
• Manages stability studies and data in the internal stability management software
• Provides user training and support for the stability program
• Enters stability data and manages the cross-functional review
• Contributes to the stability design and data gathering for shelf-life extension
• Manages the review and approval of various internal stability documents used in current Good Manufacturing Practices (cGMP) ensuring accuracy and appropriate format according to procedures
• Ensures out-of-trend or atypical results are addressed and support any on-going investigations
• Performs data verification for regulatory filings and other stability reports
• Participates in cross-functional project team meetings to provide stability updates as needed
• Supports activities for change control, corrective actions, management review and metrics reporting
• Identifies preventive action and continuous improvement opportunities
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements as applicable
• Adheres to all department and company-wide policies regarding conduct, performance, and procedures
• Provides oversight and direction to direct and indirect reports, as applicable (if assigned in the future), in accordance with the organization’s policies and procedures
• Performs other duties as assigned

Qualifications

• Required: Bachelor’s degree in a scientific discipline; at least 6 years of Quality Assurance experience in the biopharmaceutical industry with at least 1 year of stability program experience
• Preferred: Prior project management experience
• Required: Ability to use written and verbal communication skills to communicate complex scientific, medical and program issues
• Required: Ability to partner with cross-functional teams from research, pre-clinical development, manufacturing, quality, regulatory and clinical development
• Required: Outstanding flexibility and adaptability suited for the changing requirements and fast pace of a small biotechnology company
• Required: Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
• Required: Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment

Skills

• Written and verbal communication
• Cross-functional collaboration
• Project management (preferred)
• Quality systems and cGMP knowledge

Education

• Bachelor’s degree in a scientific discipline

Additional Requirements

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