Senior Manager, Good Pharmacovigilance Practice (GVP) Quality

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 30, 2020
Ref
R0013959
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite, a Gilead Company, is a commercial-stage biopharmaceutical company focused on the development and 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. 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.

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Senior Manager, Good Pharmacovigilance Practice (GVP) Quality (Senior Manager, Quality Assurance)

We are seeking a highly motivated individual for the role of Senior Manager, Good Pharmacovigilance Practice (GVP) Quality at Kite Pharma. This is a hands-on role where you will perform quality assurance activities to ensure that the company's Pharmacovigilance activities are conducted in accordance with GVP guidelines, applicable regulations and company policies and procedures.

Specific Job Responsibilities:
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • Perform internal and external pharmacovigilance audits (Internal, Third Party, Vendor, Systems) and compliance assessments including Risk Evaluation & Mitigation Strategies (REMS), audits to ensure compliance with GVP guidelines, applicable regulations and company policies and procedures
  • Manages the end to end processes related to the planning, conduct and reporting of GVP and REMS audits
  • Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
  • Implements and maintains programs and processes to ensure high quality products and compliance with current Good Pharmacovigilance Practices (GVPs)
  • Develop, review, and revise audit plans and tools, SOPs, guidelines, and other documents
  • Support effectiveness checks and CAPAs
  • Assists with inspection readiness activities for third party audits of Kite including regulatory authority inspections and coordinates tracking of document requests, responses, and supporting documents during inspection.
  • Provides interpretation and guidance for internal and external customers on GVP related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies.
  • Contributes to the development of continuous quality process improvements
  • Establish and maintain quality compliance data and audit metrics
  • Interface with regulatory agencies as required.
  • Performs other duties as assigned
  • This position may require up to 40% travel


Basic Qualifications:

Bachelor's degree with 8+ years of GVP or quality systems experience

OR

Master's degree with 6+ years if GVP and/or quality systems experience.

Additional Knowledge, Skills & Experience:
  • In depth knowledge of global ICH GCP, GVP, FDA, EMA and other ICH and general compliance and audit concepts
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Experience with project management, preparing presentations, and operational excellence
  • Prior experience with Regulatory Authorities (FDA, EMA, MHRA, etc)
  • Prior Audit experience, 4+ years
  • Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
  • Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
  • Proficient in Microsoft Office Suite and other applications
  • Excellent interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Prior experience in Cellular Therapy is preferred
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
  • Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.


(This role is able to be Remote or Santa Monica based.)

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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.