Director, Quality Assurance

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 Quality Assurance to join our is a hybrid position with2days a week onsite from our Pasadena or San Diego CAofficeSummary: Responsible for the quality systems that assure external parties (CDMOs CROs contract laboratories and service providers) and internal employees operate in a state of compliance. This role is responsible for resourcing and performance of four connected quality programs: (1) GMP/GLP supplier quality management including qualification periodic review and disqualification; (2) the internal audit program; (3) the GMP training program including onboarding and role-based curriculum/training assignment; and (4) quality support for Xencors Qualified Person (QP) service providers including preparation and maintenance of QP Declarations (QPDs) and support of batch certification activities for EU/UK Duties:GMP/GLP Supplier Quality ManagementResponsible for the end-to-end supplier qualification lifecycle for GMP and GLP suppliers: initial assessment risk classification qualification requalification performance monitoring and the Approved Supplier List (ASL) and ensure qualification status is accurate current and inspection-ready in Veeva Vault Xencors quality management system of record (Vault QMS / QualityDocs).Apply risk-based supplier categorization consistent with ICH Q9 ICH Q10 EU GMP Chapter 7 (Outsourced Activities) EU GMP Chapter 5 (starting-material supply chain controls) and 21 CFR 210/211 and 21 CFR 58 negotiate and maintain Quality Agreements / Technical Agreements with CDMOs contract testing laboratories GLP test facilities and quality service providers; ensure responsibility matrices are unambiguous and the supplier audit program: lead audits (on-site remote and hybrid) qualify and direct third-party auditors and set audit frequency by risk; review audit reports drive CAPA responses to closure and escalate unresolved risk to Quality sourcing and CMC/Clinical Operations partners with quality input during vendor selection and Audit ProgramResponsible for the internal audit program end to end: multi-year risk-based audit schedule audit plans execution reporting CAPA verification and program internal audits of GMP/GLP-relevant Xencor processes and quality systems (document control training deviations/CAPA change control supplier management data integrity computerized systems product/annual quality review and virtual-sponsor oversight controls).Track and trend audit findings; identify systemic issues and drive remediation with process Training Program Onboarding & Training AssignmentResponsible for the GMP training program and the learning management functionality within Veeva Vault and maintain role-based curricula and job/training matrices; execute training assignment reassignment and periodic requalification for all GMP-impacted and deliver new hire and ongoing GMP/GxP training content: annual GMP refresher data integrity deviation/CAPA and root cause analysis change control documentation practices and topic-specific training driven by CAPA or regulatory change; ensure training is completed and documented prior to independent performance of GMP Service Provider Support QPDs and Certification ActivitiesServe as the primary QA point of contact for Xencors contracted QP service provider(s) and EU/UK importation review and maintain QP Declarations (QPDs) for API manufacture in accordance with Article 46(f) of Directive 2001/83/EC and for investigational products Article 61 / Annex 13 and Regulation (EU) 536/2014 expectations; coordinate the supporting audit evidence GMP certificates and manufacturing-site information required to support each QP oversight expectations under EU GMP Annex 16 (including Article 51(3) responsibilities and reliance on audits performed by third parties) and coordinate the QPs site knowledge audit access and information certification and release timelines against clinical supply demand; escalate risks to Clinical Supply CMC and Quality importation and QP-related documentation for clinical trials (e.g. EU CT number/CTIS-linked supply RGL/import authorization prerequisites) in partnership with Regulatory Affairs and Clinical the QP-related document inventory (QPDs GMP certificates MIA/manufacturing authorizations audit reports supporting reliance) and ensure currency ahead of 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:Bachelors degree in a life science engineering or related discipline; advanced degree preferred. More than 12 years of progressive GMP quality experience within the biopharmaceutical industry including demonstrated end-to-end ownership of supplier quality and audit programs and prior people-management experience. Demonstrated lead auditor experience auditing GMP suppliers and/or GLP test facilities including hosting or directly supporting health authority also requires:Working knowledge of 21 CFR 210/211 21 CFR 600s 21 CFR 58 EU GMP Volume 4 (including Chapters 5 and 7 and Annexes) ICH Q7/Q9/Q10 and Regulation (EU) 536/ experience with QP interactions QP Declarations and EU/UK batch certification and importation owning or substantially supporting a GMP training program including role-based curriculum design and LMS training -on experience administering an electronic QMS; direct Veeva Vault experience (QMS QualityDocs and Training) strongly to operate effectively in a virtual/outsourced operating model with strong written documentation prefer certified auditor credential (ASQ CQA CBA) or equivalent qualification experience supporting FDA and EU/MHRA inspections and partner audits and experience supporting commercial-stage readiness in addition to clinical-stage 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 domestic and international travel for supplier and internal audits: approximately 1525%. Occasional off-hours communication to align with EU-based QP providers CDMOs and contract 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.