Quality Systems Manager

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 11, 2019
Ref
R0009027
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual to join us as a Quality Systems Manager. This individual will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy and serve as the audit management lead for the Santa Monica Clinical Manufacturing sites. This role will be a hands-on resource reporting to the Associate Director of Quality Systems.

Responsibilities (include but are not limited to):

The Quality Systems Manager will lead the site Document Management and support oversight of Kite's Quality Systems (Audit, Change Control, Deviation, CAPA, Effectiveness Verification, Quality Metrics Review, Quality Council and Training). This position will be located at Kite's clinical manufacturing site in Santa Monica, CA. Job responsibilities include but are not limited to:
    • Responsible for the management of all lot documentation and records issuance processes to support clinical manufacturing.
    • Provides guidance and advice on approved procedures, standardization and requirements associated with the lot document management system.
    • Manages Document Management team and processes are performed in compliant and timely manner.
    • Coach and develop, provide continuous feedback and documents performance evaluations for Quality Systems reports.
    • Collaborates with cross-functional departments and global counterparts to ensure timely implementation of changes to the document management documents and systems.
    • Investigates deviations against the lot documentation and records issuance system and develops effective corrective action plans.
    • Provides, tracks and trends department metrics.
    • Lead intra- or interdepartmental teams of an operational nature such as preparing for minor changes in regulations, and/or continuous improvement initiatives.
    • Coordinate and reviews the work of others.
    • Maintains awareness of key issues and concerns to Senior Management as appropriate.
    • Review and approve procedures, which include, but are not limited to, SOPs, Controlled Forms, and Work Instructions.
    • Ensure Quality Systems conformance to regulations and quality policies.
    • Develop, track, and communicate site metrics to management.
    • Manage, prepare and review quality related activities for Quality Council.
    • Provide and support quality assessments of internal operations and suppliers to analyze compliance and assess risk.
    • Support internal and external audits and participate in the site audit walkthrough program
    • Support Change Control system and ensure proper maintenance and approval of cGMP related activities.
    • Support the Deviation, LIR, CAPA and EV system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
    • Support training process activities and the associated Learning Management System.

Requirements:
    • Bachelor's of science degree with a minimum of 8 years of combined technical and training experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. Knowledge of training processes/systems and regulatory requirements (21 CRF Part 11/210/211)
    • Minimum of 3 years of working within or directly with Quality Systems
    • Through knowledge of regulatory requirements for applicable regions
    • Understands current global and regional trends in regulatory compliance
    • Strong knowledge of GMPs
    • Knowledgeable of change control practices/strategies
    • Experience in identifying, writing, evaluating and closing investigations
    • Advanced Skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat
    • Ability to communicate and work independently with scientific/technical personnel
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
    • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
    • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload and schedule based upon changing priorities

Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Drive and right off the 10. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commiserate to any large corporation.To learn more about us, please visit our website atwww.kitepharma.com.

If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

No phone calls please and no agencies or recruiters.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.

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