Senior GMP Compliance Auditor

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 22, 2020
Ref
R0015116
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

We are seeking a highly motivated individual to join us as a Sr. GMP Compliance Auditor in the Corporate Quality and Compliance department. In this role, you will participate in programs to improve GMP compliance and supportthe Senior Director along with site management in the preparation and management of audits.

Responsibilities (include but are not limited to):
  • Assist in the scheduling, performance, and tracking of Kite Audits in accordance with regulatory and company requirements.
  • Lead several aspects of Internal and External audits: planning the audits, documentation, providing copies of requested documents, attending pre and post audit meetings, informing appropriate management, report generation and reviewing documentation of audit closure and follow-up for findings.
  • Provide compliance expertise and support for the maintenance and continual development (or modification) of Kite's audit program; include and implement all applicable regulatory and company requirements.
  • Responsible for review of audit reports prior to distribution.
  • Prepare accurate and timely reports according to established procedures.
  • Perform analyses of audit findings to identify any trends among noncompliance items.
  • Maintain accurate records of audit findings and activities.
  • Ensure that the audit program is up to date by tracking and reviewing Audit Master Schedule.
  • Provide support for all quality-related issues.
  • Provides training and competency.
  • Create and sustain a culture that is based on continuous improvement.
  • Execute audits to verify compliance with global Good Manufacturing Practices regulations, product CMC license/dossier filings, and corporate requirements.
  • Assist with the planning and execution of External and Internal Audits.
  • Support or act as lead auditor at manufacturing site internal audit(s).
  • Assure tracking of key performance metrics and participate in periodic reviews to ensure suitability and effectiveness of the audit program.
  • Assure communication of compliance concerns, regulatory agency expectations and industry trends as part of on-going education and training for GMP compliance.
  • Work closely with Kite manufacturing sites in areas of GMP compliance.
  • Act as internal compliance consultant and/or provide other resources with expertise.
  • Support and assist other compliance team members with regulatory commitments, BPDRs, regulatory intelligence, MRB, inspection readiness activities and quality escalations.
  • Identify opportunities for improvement, as well as identification and implementation of appropriate actions.
  • Ability to travel up to 25%.
  • Perform other duties as assigned.


Basic Qualifications:
  • Bachelor's degree in life sciences or engineering discipline with 7 years of experience in regulated industry, biologics or biotech

OR
  • Master's degree in life sciences or engineering discipline with 5 years of experience in regulated industry, biologics or biotech


Preferred Qualifications:
  • 3+ years auditing experience in biologics, international experience
  • American Society for Quality (ASQ), Certified Quality Auditor credentials
  • Working knowledge of the regulatory environment for the manufacture of drugs, biologicals and cellular therapy products.
  • Knowledge of blood/tissue components regulations a plus.
  • Good understanding of global cGMP regulations and ISO standards.
  • Strong analytical and demonstrated problem solving skills.
  • Strong database management, including development, maintenance, and evaluation (metrics).
  • Excellent verbal and written communication skills.
  • Success working with multi-functional, global teams.
  • Excellent interpersonal/communication/influencing/negotiation skills required.


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.