Manager, Quality Assurance

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 is seeking a highly motivated individual contributor to join our External Quality team as Manager, Quality Control. This role will report to the Director, External Quality. Scope of the External Quality group includes Quality oversight of contract service providers such as manufacturing organizations (CMOs), contract testing labs (CTLs) and Quality support for Partnerships spanning clinical and commercial operations within the cell therapy space.

The Manager 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 excellent 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.

Responsibilities:

• Assist External Quality Director to oversee and support one or more external testing partners and implementation of day-to-day External Quality operational responsibilities related to the partnership.

• Support of strategic alliance partners on successful product launch including but not limited to establishing and managing Joint Quality Councils, communicating and helping partners to assess impact of changes, tech transfer, product harmonization, fielding regulatory inquiries, and supporting the cross-functional team on all Quality related matters.

• Review and data analysis/trending to understand the external testing partner issues and provide recommendations in technical results.

• Initiate, review and/or approval of GMP records and documents (both internal and external) including but not limited to method SOP, investigations, corrective actions, change controls, protocols and reports.

• Support External Quality Director to perform data verification including but not limited to annual Product Quality Reviews, filings, Quality Agreements.

• Overseeing of contract testing lab original data, report, critical issues or risks. Organization and oversee the progress and data relating to viral vector release.

• Supporting regulatory agency inspections for all inquiries relating to contract testing laboratory operations.

• Understand Gilead business model and organization priorities.

• Up to 10% travel

Basic Qualifications:

• Master’s Degree and 4+ years biopharmaceutical/cell therapy Quality Control experience OR

• Bachelor’s Degree and 6+ years biopharmaceutical/cell therapy Quality Control experience OR

• High School Degree and 11+ years biopharmaceutical/cell therapy Quality Control experience

Preferred Qualifications:

• Experience working with Quality Assurance

• Experience working with CMOs and/or CTLs and/or supporting alliances/partnerships

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

• 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.

• Knowledge and experience across various GXP settings, preferably in cell therapy, biologics, biopharmaceuticals

• Exhibit direction skills and strategic, network-based thinking.

• Experience with direct Regulatory Agency (e.g. FDA) interaction.

• Experience auditing and performing due diligence assessments for CMOs/CTLs

• Experience writing, evaluating and closing investigations, CAPAs and Change Control records

• International partnership experience (e.g. CMO, CTL and/or Strategic Partners)

• Cultural sensitivity and understanding of regional and global perspectives/marketplace

• Previous experience in people direction

• Excellent oral and written communication skills in English.

• Meaningful interpersonal skills, open minded to the diverse opinions of others and able to lead effectively through influence

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

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

Does this sound like you? If so, apply today!