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Senior Manager, Quality Assurance Operations

United States - California - El SegundoQualityRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything we do, from early research to product development.

We are looking for a Senior Manager, Quality Operations at our El Segundo, CA location. This role will report into the Director of Quality.

Responsibilities:

  • Manage and schedule Receipt and processing of incoming apheresis materials
  • Oversee lot-related final product labels and documentation and ensures resolution of issues to release for manufacturing
  • Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews
  • Establish KPI’s for the group and customer base across Kite
  • Provide QA oversight and approval of deviations.  Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines
  • Review and approve final Apheresis shipment authorization to clinic
  • Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
  • Ensures that inspection of incoming labels is performed and executed
  • Leads compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues
  • Oversee the packaging and shipping process; authorize shipment
  • Provide QA oversight and approval of CAPAs.  Ensures that associated CAPAs are initiated and resolved, as needed
  • Provide QA oversight and approval of change records.  Ensures that change records are initiated and resolved, as needed
  • Support QA on the floor processes, including batch record review
  • Ensure process control measures are in place and followed in product manufacturing
  • Maintain metrics related to Accessioning review and incoming label in support of monthly Management Review
  • Generate, approve and update procedures and forms as needed
  • Maintain and develop organizational structure to meet business needs
  • Position will manage 7 days a week operation with Days and Graveyard team(s)

Basic Qualifications:

  • Master’s Degree and 6+ years’ experience in a pharmaceutical, biotech, or biologics operation with Supervisory experience OR
  • Bachelor’s Degree and 8+ years’ experience in a pharmaceutical, biotech, or biologics operation with Supervisory experience OR
  • High School Degree and 12+ years’ experience in a pharmaceutical, biotech, or biologics operation with Supervisory experience

Preferred Qualifications:

  • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
  • Ability to effectively negotiate and build collaboration amongst individuals and peers
  • Good interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities

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