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 position is a hybrid role with 2 days a week onsite in our San Diego CA. : Responsible for managing the Quality Assurance Departments GCP compliance projects and activities in compliance with Xencor Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and applicable regulatory Responsibilities: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 and assesses risk areas and supports the development and implementation of risk mitigation measuresSupports the development and implementation of audit plans and annual GCP audit strategyPerforms audits of clinical investigator sites clinical vendors and Xencor processes and systems for compliance with governing proceduresEvaluates current quality systems processes procedures and protocols for complianceSupplements the development of internal SOPs policies and procedures as requiredEscalates regulatory compliance risks to Quality and Clinical Leadership to ensure that all issues are mitigated in a timely mannerPerforms timely and effective follow up of quality issues including those issues that result in the implementation of a Xencor Corrective and Preventative Action (CAPA) PlanMaintains up-to-date working knowledge of national and international standards and guidelines related to GCPSupports the understanding communication and coordination of clinical quality / compliance initiatives and QA compliance standards to internal stakeholders Delivers GCP training across the organization as neededGuides Clinical Development on internal and external regulatory and quality auditsProvides 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 vendorsWorks with Clinical to track and ensure external Clinical vendors are audited on an appropriate scheduleSupports Xencor clinical trial teams to remain inspection-ready and compliant with internal processes study protocols ICH-GCP and applicable regulationsServes as a subject matter expert on GCP compliance related issuesAdheres to all department and company-wide policies regarding conduct performance and proceduresPerforms other duties as assigned. Education/Experience/Skills:Position requires a minimum of a bachelors 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 also requires:Ability to work independently with minimal supervisionStrong computer skills including proficiency in use of Microsoft Outlook Word Excel and PowerPointStrong knowledge of regulatory compliance and QA issues within a pharmaceutical biotech or medical device organizationKnowledge of current US FDA Regulations and ICH Guidelines governing clinical trials and recent global regulatory initiativesAbility 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 companyKnowledge of computer software including relevant applications such as MS Word Excel and PowerPointFamiliarity with relevant laws legal codes government regulations and agency rulesStrong foundational knowledge and functional understanding of ICH GLP cGMP requirements and GXP regulationsAttention to detail organizational skills ability to multitask and follow tasks through to completionAbility to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelOccasional 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: $159500 - $184000The 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.