Supervisor, Quality Control

Specific Responsibilities

• Lead a team of high-performing individuals, with particular focus on individual development in support of greater team achievement.
• Drive a culture of Operational Excellence in the group.
• Supervise Analytical QC testing and various other support activities performed in the Analytical QC Lab.
• Review of records, generation of CoAs for product release.
• Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
• Responsible for overseeing on-time completion of training for the group.
• Monitor GMP systems currently in place to ensure compliance with documented policies.
• Expectation includes a hands-on, collaborative approach to problem solving, planning, and people-management.
• Participate in and support development and implementation of Operational Excellence initiatives to enhance laboratory and staff efficiencies.
• Participate and/or lead daily and weekly team meetings.
• Work with internal and external resources to maintain analytical equipment in an optimal state.
• Oversee purchase and qualification of equipment, materials and media required for routine testing and reagent qualification.
• Responsible for OOS, lab and protocol deviations, and corrective action plan implementation when necessary.
• Provides input and support in the development, revision and review of SOPs, protocols and reports.
• Participate in inspections by both internal and external stakeholders as needed.

  Basic Qualifications

  • MA / MS Degree with 3+ years of analytical and/or cGMP operations and/or quality experience OR
  • BA/BS Degree with 5+ years of analytical and/or cGMP operations and/or quality experience OR
  • High School Degree with 9+ years of analytical and/or cGMP operations and/or quality experience

    Preferred Qualifications

    • Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry.
    • Demonstrated guidance and overseeing skills, including establishing direction and goals, and guiding implementation while fostering a team-based environment.
    • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
    • Experience in any of the following analytical techniques, Flow Cytometry, PCR, ELISA, cell viability measurement.
    • Familiarity with FDA, EU and ICH guidelines.
    • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP.
    • Comfortable in a fast-pace company environment with minimal direction and able to adjust workload based on changing priorities.
    • Ability to think critically and demonstrate troubleshooting/problem solving skills.
    • Excellent skills in Microsoft Office, data analysis software, and other related applications.

      Pay Range

      The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary.

      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.