Quality Systems Senior Manager

We are seeking a highly motivated individual to join us as a Quality Systems Sr.Manager reporting into the Global Quality Systems Director. In this position, you will establish and maintain a compliant and effective Quality Management System governance structure for globalized Cell Therapy in compliance with Kite requirements.

Responsibilities include (but are not limited to):

• Facilitate Policies/SOPs Community of Practice to include:
  • Assess proposed new document and document change for impact to other sites, documents, policies, QMS hierarchy, etc.
  • Ensure Gap Assessments are completed against Policies Requirements and Procedures as applicable
  • New document or document change proposal is assessed per expected requirements
  • Ensure Policies, and Core Standard Operating Procedures (SOPs) are in alignment with applicable health authority regulations, guidance documents, and industry standards.
  • Ensure appropriate cross-functional reviewers/approvers are identified.
  • Assure consistency across the network in the manufacture, testing and release processes for products like Yescarta
• Lead Next Generation QMS Business work stream
• Support audits (internal, external) to verify regulatory and quality requirements have been met.
• Develop and execute strategic initiatives for continuous improvement of Kite Quality System
• Lead Quality Culture project for Corporate
• Perform other duties as required
• The standard work week for this position is M-F with occasional weekend work required.

Qualifications:

• Bachelor's Degree and 8 years of experience in Quality Systems.
• Strong knowledge of GMP, SOPs and Quality System processes.
• Excellent organizational skills and ability to review and update processes or procedures.
• Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems.
• Strong knowledge of Quality Management systems practices/strategies
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Experience in pharmaceutical or bio-pharmaceutical field.
• Education or training in cell culture and gene therapy manufacturing environment a plus.
• Proficient in drafting and completing technical documents and presentations.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

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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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