Manager, Quality Assurance GCP

Regulatory Affairs · San Diego, California
Department Regulatory Affairs
Employment Type Full Time
Minimum Experience Senior Manager/Supervisor

Xencor is an innovative, clinical-stage biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for an experienced Manager, Quality Assurance GCP.

 

Our protein engineering capabilities and the modular nature of our technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are developing a broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing worldwide.

 

Our employees are the most important factor in our success, and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees’ value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.

 

We currently have an excellent opportunity for a talented Manager, Quality Assurance GCP to join our team!  


Summary:

 The Manager, Quality Assurance GCP is responsible for QA GCP activities including developing, implementing, and maintaining a system of quality to ensure Xencor clinical trial activities are performed, the data are generated, documented and reported in compliance with Xencor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.   This role is also responsible for compliance with applicable Corporate and Divisional Policies and SOPs. This position can be located at either the Monrovia or San Diego facility with regular travel to the other site.


Job Duties Include:


  • Supports the ongoing development and maintenance of the Xencor Clinical Development Quality Management System (QMS)
  • Identifies and assesses compliance risk areas and supports development and implementation of risk mitigation measures
  • Promotes understanding, communication and coordination of the Xencor quality and compliance standards
  • Schedules, performs, and documents external QA audits of vendors and investigator sites participating in Xencor sponsored clinical trials; includes vendor qualification audits/assessments
  • Schedules, performs, and documents internal QA audits of Xencor processes and systems to assure compliance with governing procedures
  • Supports the development and implementation of audit plans and annual GCP audit strategy
  • Supports the development of processes and tools compliant with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)–GCP principles, FDA/EMA/MHRA or other applicable global health authority regulations related to GxPs
  • Assists in the development of SOPs and other quality documents
  • Ensures 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
  • Conducts/delivers annual GCP training for Xencor Clinical Development and Regulatory Affairs (RA) personnel; supports the delivery of additional training as required
  • Promotes understanding, communication and coordination of QA compliance standards; may include review and input on clinical trial protocols and other clinical trial documents, when applicable
  • Supports Xencor clinical trial teams to remain inspection-ready and compliant with internal processes, study protocols, ICH-GCP and applicable regulations
  • Assists with compliance checks across clinical trial activities to ensure adherence to quality management processes, SOPs, and trial specific plans  
  • Performs ongoing review, tracking, and reporting of data and documentation to monitor quality activities and support trending/signal detection of potential quality concerns
  • Provides consultive support to Clinical Development and RA personnel for internal and external regulatory and quality audits, inspections and other quality activities (e.g., gap analysis, etc.)
  • Assists in preparing investigator sites participating in Xencor-sponsored clinical trials for regulatory inspections
  • Maintains current working knowledge of national and international standards and guidelines related to GCP activities
  • Collaborates effectively with all functions within QA, Clinical Development and RA, and other applicable departments within Xencor as required
  • Other duties as assigned


Job Qualifications:


  • Requires a minimum of a Bachelor’s degree and at least 5 years of experience in clinical drug trial development within a pharmaceutical or biotech environment (CRO experience may be considered)
  • Requires 3 years of auditing experience in clinical research, regulatory compliance, GCP and/or quality assurance environment
  • Ability to establish and maintain effective working relationships with coworkers, managers and vendors
  • Excellent analytical and organizational skills with strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  • Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint (advanced Excel knowledge required), SmartSheet
  • Strong oral and written communication skills
  • Working knowledge of regulatory compliance and QA issues within a pharmaceutical or biotechnology company
  • Current knowledge of ICH GCP Guidelines governing clinical drug trials and recent global regulatory initiatives
  • Certified Quality Auditor (CQA) preferred
  • In-house role with minimal travel required (average travel expectation of 25% or less)


Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

 

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

 

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

  • Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
  • Ability to work and sustain attention with distractions and/or interruptions.
  • Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
  • Ability to maintain regular attendance and be punctual.
  • Ability to understand, remember and follow verbal and written instructions.

Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

 

Americans with Disabilities Act (ADA) Statement

The 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 HR@xencor.com.

 

To 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 functions.

 

Equal Employment Opportunity (EEO) Statement

The 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 law.

 

Xencor 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.

 

 

Thank You

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  • Location
    San Diego, California
  • Department
    Regulatory Affairs
  • Employment Type
    Full Time
  • Minimum Experience
    Senior Manager/Supervisor