Director QA, Supplier Quality Management

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 11, 2019
Ref
R0007938
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Kite Pharma is a commercial and clinical-stage biopharmaceutical company focused on the development and further commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.

We are seeking a highly motivated individual to join us as a Director QA, Supplier Quality Management (SQM) for contract manufacturing organizations (CMOs), contract test labs (CTLs), third party logistics (3PLs) (couriers, cryoshippers, remote warehousing) and GMP service providers (e.g. calibration, cleaning). You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross functionally and globally to execute and further define the SQM program for CMOs, CTLs, 3PLs and GMP service providers. This role will be a hands-on resource reporting to the Sr. Director, Corporate QA.

Responsibilities (include but are not limited to):

Responsible for contract manufacturing organizations (CMOs), contract test labs (CTLs), third party logistics (3PLs) (couriers, cryoshippers, remote warehousing) and GMP service providers in Corporate QA, Supplier Quality Management:

    • Accountable for the GMP compliance of: audits, QTAs, SCARs, management of supplier initiated changes.
    • Manage cross-functionally and globally (Supply Chain, Process Sciences, Manufacturing, Regulatory Affairs, Site QA and Site QC) within Kite and externally to assure compliance and strong relationships with the CMOs, CTLs, 3PLs and service providers.
    • Collaborate within SQM team to manage:
      • Supplier qualification and specification development processes that use risk-based tools for qualification, classification and performance monitoring.
      • Supplier QTA process to assure key quality expectations are reflected in supplier's operations and updates for changes are managed.
      • Supplier initiated change notifications
      • Phase-appropriate supplier qualification requirements
    • Manage a QA Operations function for disposition, quality issues, change records, protocol review/approvals, etc at CMOs.
    • Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained.
    • Monitor and report on meaningful SQM performance metrics as well as Supplier performance metrics.
    • Provide leadership and direction for CMO, lab-related or service provider issues - SCARs, CAPAs, OOS, deviations and change records.
    • Collaborate with the Global SQM team to improve processes/share responsibilities as Kite continues to expand globally
    • Participate as a representative of SQM for various internal project teams as well as joint committee meetings with suppliers
    • Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance
    • Lead supplier related investigations as necessary
    • Lead, develop and manage staff.
    • Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
    • Ability to travel up to 20%
    • Perform other duties as assigned.


Requirements:
    • Bachelor's degree in biological sciences or related field with minimum of 10 years experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred
    • Previous experience managing and developing staff with a minimum of 8 years of experience.
    • Experience auditing CMOs, CTLs, calibration, 3PL, sterilization facilities.
    • Experience with direct FDA interaction (or other regulatory agencies) required
    • ASQ Certified Quality Auditor preferred
    • Experience writing, evaluating and closing investigations, CAPAs and change control records.
    • In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
    • Willingness to think outside of the box and adapt best practices to this small, but growing environment
    • Proficient in MS Word, Excel, and Power Point
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
    • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
    • 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.


No phone calls please and no agencies or recruiters.

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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