Manager Quality Assurance
Xencor is an innovative, clinical-stage biopharmaceutical 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 a Manager, Quality Assurance to join our team.
Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.
The successful candidate for Manager, Quality Assurance is self-directed, detail-orientated, proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase company.
Job duties and responsibilities:
- Collaborate with senior QA staff to maintain programs and processes that ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
- Manage the Change Control/Deviations/CAPA programs
Drive continuous improvement activities with emphasis on impact assessment and root cause analysis (RCA)
Provide training as needed
Participates in execution of assessments and RCA
- Manages internal audit program to ensure compliance with established internal procedures and GXP regulations
- Manage the Quality Management Review program
- Participates in cross-functional process improvement initiatives
- Draft, reviews, and approves Standard Operating Procedures as applicable
- Collaborates with the Xencor Chemistry, Manufacturing and Controls (CMC) group to support day to day GMP operations as needed
- Support clinical batch disposition through review of external batch records, deviations, CAPA, change controls
- May support QA review of potency data as needed
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Job Requirements and Qualifications:
- BS/BA degree in related discipline and minimum eight (8) years of related QA experience; or,
- MS/MA degree in related discipline and minimum six (6) years of related QA experience; or,
- PhD in related discipline and minimum four (4) years of related QA experience, or;
- Equivalent combination of education and experience
- Experience in a clinical phase biologics
- Experience with Contract Manufacturing Organizations
Skills and Abilities:
- Knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues (21 CFR part 11,210/211; Eudralex Volume 4, MHRA UK GMP, and ICH guidelines)
- Knowledge of effective root cause investigation including industry best practice methods, corrective and preventive action planning and execution and verification of effectiveness techniques.
- Experience with quality tools (Veeva QMS preferred) and process improvement techniques
- Computer literacy in Microsoft Office Suite (MS Word, Excel and PowerPoint).
- Demonstrate ability to be self-directed while managing multiple projects
- Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
- Strong written and oral communication skills
- Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines with appropriate sense of urgency in a nimble fast paced matrixed environment
- Strong problem solving and analytical skills with demonstrated ability to be detail oriented
- Proven ability to work collaboratively within a cross-functional team to negotiate effective solutions using strong interpersonal and social skills.
- Facilitates uniform standards and enables best practice sharing
- Adherence to high ethical and quality standards that focus on patient first values
Travel: Some travel is required (10%)
The physical 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 association 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. Work is performed in an office environment.
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package.
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.