QA Specialist III

职位描述

We are seeking a highly motivated individual contributor to join us as a QA Specialist III within External Quality embedded within Kite’s External Quality Organization. The QA Specialist III will report to the Quality Director, External Quality. Scope of the External Quality group includes quality oversight of contracted service providers such as development and manufacturing organizations(CMO/CDMO), contract testing labs (CTLs) and quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space.

The QA Specialist III will have opportunities to work and share knowledge with partners across Kite’s Global Technical Operations (e.g. Quality Control, Analytical Development, Process Development, Quality, Manufacturing, Supply Chain, and Regulatory) as well as international partners. The ideal candidate will have strong technical skills (knowledge of one or more of the following: cell therapy, bioassays, viral vector, and testing operations), Quality and Compliance background (Biologics, Drug, regulation), and understanding of the drug development lifecycle.

This position will be based at Kite’s headquarters in Santa Monica, CA.

Responsibilities of the QA Specialist III include:

• Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities.

• Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records, investigations, corrective actions, change controls, protocols and reports, annual product quality reviews, IND/BLA/MAA CMC modules, Quality Agreements.

• Compilation of critical material and product disposition packages. Project management of disposition deliverables (e.g. investigations, batch records) ensuring timely critical material and/or product supply.

• Perform disposition (release) of product from CMOs.

• Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kite's CMOs.

• Assist, gather and analyze information to support External Supply Quarterly Management Review, provide mitigation plans for issues and risks.

• Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations.

• Up to 10% travel (domestic)

Basic Qualifications:

• Master’s Degree and 3+ years’ experience in GMP environment related field OR

• Bachelor’s Degree and 5+ years’ experience in GMP environment related field

Preferred Qualifications:

• Working with or at contract manufacturing or testing organizations or supporting partnerships.

• Diplomacy skills and ability to assess performance and proactively identify and mitigate risks

• Experience with collaborating in a cross-functional working model with support from fully-and partially dedicated resources; ability to manage through influence.

• Experience with direct FDA interaction (or other regulatory agencies)

• Experience writing, evaluating and closing investigations, CAPAs and change control records.

• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies

• Excellent oral and written communication skills

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

• Previous experience in Quality Control, Quality Assurance or Analytical Science

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.