QA Specialist III

Kite Pharma • Santa Monica, CA

6d • Onsite

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. 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. 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 Senior Manager, 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 a 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.

Requirements

• 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 OR
• High School Degree and 9+ years’ experience in GMP environment related field

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees