Director, External Quality Assurance (GMP)

Introduction: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 Director External Quality Assurance (GMP) to join our is a hybrid position with2days a week onsite from our Pasadena or San Diego CAofficeSummary: Responsible for leading Quality GMP manufacturing and testing activities at external vendors supporting both early and late phase development and ensuring compliant product release effective vendor management and alignment with global GxP Duties:Provides oversight of Quality Assurance activities at GMP external vendors for manufacturing and testing operations ensuring compliance with global GxP regulations quality standards and and/or performs QA product release activities. Directs support staff on performing product release activities. Manages and performs review and approval of GMP external vendor documentation. Directs support staff on performing vendor product documentation as the QA representative for multiple products in internal and external vendor product team timely resolution of operational and quality strong working relationships with vendor operational teams to ensure clarity of expectations and consistent collaborative relationships with vendors while providing quality guidance and oversight to ensure consistent adherence to established QA standards and performance vendor performance identifies trends gaps and risks in day-to-day operations and initiates corrective actions within defined structured Vendor business reviews and performance with Vendor Management to address performance issues and enforce incremental improvements using existing continuous improvement methodologies and root cause analysis for recurring or critical issues and ensure alignment with established remediation enhancements to current frameworks based on observed operational with cross-functional stakeholders to ensure alignment with existing governance and operational a culture of quality and disciplined adherence to established data entry functions as required by procedure Authors reviews and approves various internal documents ensuring accuracy and appropriate format according to proceduresManages creation and review of documents used in Good Manufacturing Practices (GMP) Perform QA activities such as authoring reviewing approving and/or managing change controls deviations and corrective actions as needed. Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete current knowledge of global regulatory expectations industry standards and emerging quality practices applicable to pharmaceutical development manufacturing and commercialization to all department and company-wide policies regarding conduct performance and proceduresProvides oversight and direction to direct and indirect reports as applicable (if assigned in the future) in accordance with the organizations policies and procedures. The responsibilities may include but are not limited to recruiting training communicating job expectations appraising and managing job performance delivering feedback and coaching and providing career development planning and opportunitiesPerforms other duties as assigned. Education/Experience/Skills:Position requires a Bachelors degree in a scientific discipline plus a minimum of 12 years of GMP Quality/CMC experience with extensive CMO oversight and strong leadership governance and relationshipmanagement. Position also requires:Exceptional relationship management skills. Ability to use written and verbal communication skills to communicate complex scientific medical and program issuesAbility to partner with cross-functional teams from research pre-clinical development manufacturing quality regulatory and clinical developmentOutstanding flexibility and adaptability suited for the changing requirements and fast pace of a small biotechnology companyAbility to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelAbility to effectively manage others through coaching and supervision in accordance with company policies and practices. Ensures employee performance meets the organizations expectations for conduct productivity quality continuous improvement and goal travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $198000 - $235500The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process please contact perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential Employment Opportunity (EEO) StatementThe Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age race color religion sex sexual orientation gender or gender identity national origin disability status protected veteran status or any other characteristic protected by state or federal does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor implied or otherwise.