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: 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.
We are seeking a highly motivated individual to join us as a Sr.
GMP Compliance Auditor in the Corporate Quality and Compliance
department. This individual will participate in programs to improve
GMP compliance and support the Senior Director along with site
management in the preparation and management of audits.
Responsibilities (include but are not limited to):
Assists in the scheduling, performance, and tracking of Kite
Audits in accordance with regulatory and company requirements.
Leads 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
Responsible for review of audit reports prior to
Prepares accurate and timely reports according to established
Performs analyses of audit findings to identify any trends among
Maintains 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 as needed.
Create and sustain a culture that is based on continuous
Other compliance support duties as assigned.
Executes 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
Support or act as lead auditor at manufacturing site internal
audit(s), as requested.
Assure tracking of key performance metrics and participate in
periodic reviews to ensure suitability and effectiveness of the
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
Act as internal compliance consultant and/or provide other
resources with expertise.
Support and assist other compliance team members as needed 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.
Bachelor's degree in life sciences or engineering discipline and
7 years of experience in regulated industry, biologics or
Minimum of 3+ years auditing experience in biologics,
international experience preferred
American Society for Quality (ASQ), Certified Quality Auditor
Working knowledge of the regulatory environment for the
manufacture of drugs, biologicals and cellular therapy
Knowledge of blood/tissue components regulations a plus.
Must understand 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 multifunctional, global teams.
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 .
For jobs in the United States: As an equal opportunity employer,
Gilead Sciences Inc. is committed to a diverse workforce.
Employment decisions regarding recruitment and selection will be
made without discrimination based on race, color, religion,
national origin, gender, age, sexual orientation, physical or
mental disability, genetic information or characteristic,
gender identity and expression, veteran status, or other non-job
related characteristics or other prohibited grounds specified in
applicable federal, state and local laws. In order to ensure
reasonable accommodation for individuals protected by Section 503
of the Rehabilitation Act of 1973, the Vietnam Era Veterans'
Readjustment Act of 1974, and Title I of the Americans with
Disabilities Act of 1990, applicants who require accommodation in
the job application process may contact
email@example.com for assistance.
For more information about equal employment opportunity
protections, please view the ‘EEO is the Law’
Our environment respects individual differences and recognizes
each employee as an integral member of our company. Our workforce
reflects these values and celebrates the individuals who make up
our growing team.
Gilead provides a work environment free of harassment and
prohibited conduct. We promote and support individual differences
and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors: Everyone at
Kite is grounded by one common goal – curing cancer. Every day, we
aim to establish a direct line between that purpose and our
We are creating Kite together, with the recognition that the
best teams are built by the best people. We maintain an attitude of
curiosity, and creativity with each challenge as we develop a new
market for cancer therapies. We appreciate and respect one another,
and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as
impossible, possible, we know one thing is certain. Today is just
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