Senior Specialist, QA Compliance
KITE PHARMA, INC.
 El Segundo, CA
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Position Description

For Current Kite Pharma Employees and

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

Job Description

Kite is seeking a highly motivated individual to join us as a Senior Specialist, QA Compliance. This position will report into the Associate Director, Quality Assurance and be located in El Segundo, CA.

Responsibilities include (but not limited to):

  • Administers site internal audit program and conducts internal audits ensuring compliance of site processes and systems to FDA, EU, MHRA and ROW regulatory requirements.
  • Administers and executes site area walk through program to ensure compliance and inspection readiness of site at all time.
  • Manages site inspection readiness and inspection management programs for outside regulatory agency inspections.
  • Maintains site master file.
  • Hosts regulatory authorities during inspections.
  • Works with Regulatory Affairs and affiliates to author and provide supporting documentation and evidence for regulatory submissions.
  • Initiates and coordinates writing of regulatory commitments, responses and other correspondence.
  • Provide communications to site regarding regulatory inspection schedule and expectations.
  • Coordinate all aspects of inspection logistics at site and trains inspection support staff on specific roles, responsibilities, processes and systems associated with inspection management and support.
  • Educate site on regulatory expectations and regional inspection practices of specific countries and jurisdictions.
  • Manage and participate in internal, external and regulatory inspections and audits at the site.
  • Manage all aspects of the audit to include scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
  • Incorporate sound risk management principles for the establishment of the annual audit schedule and area walk-thrus.
  • Work directly with functional areas to ensure completion of correct CA/PA to address compliance concerns identified during audits.
  • Participate in the development, implementation and maintenance of procedures and templates to assist in the execution of the site audit program.
  • Identify compliance risks and escalate issues to appropriate levels of management for resolution.
  • Create, publish, and maintain metrics that measure the health and effectiveness of the audit program
  • Promote awareness across the commercial and clinical manufacturing platform of current regulatory agency requirements and trends
  • Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
  • Manage contractors/consultants that support the audit program. Ensure that they have the required skills, training and procedural qualification requirements
  • Develop and report trends based on internal external regulatory observations to better focus the scope of supplier audits
  • Manage the GMP certificates, QP declaration and audit attestations as needed.
  • Drive consistency with audit report observation classification, status and overall risk
  • Assist in development of effective auditing tools and training aids
  • Manage new audit requests and participate in due diligence assessments
  • Identify and drive program improvements
  • Other responsibilities as required.

Preferred

  • BS or BA degree with 7+ years of relevant experience in the pharmaceutical industry
  • Demonstrates excellent organization skills and ability to work on specified projects with tight timelines.
  • Demonstrates excellent attention to detail, and ability to consistently meet standards required in Compliance.
  • Demonstrates excellent verbal, written and interpersonal skills.
  • Demonstrates a full working understanding of compliance requirements.
  • Extensive understanding of GMPs, FDA, EU and ROW regulatory requirements.
  • Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, 820; , 1985, F-27, Section 30; as well as ICH, ISO and USP / EP compendial standards and principals.
  • Experienced auditor with 2 years' experience and ability to perform on-site as well as investigative audits.
  • Detailed knowledge of the regulatory requirements related to Cell Therapy, Biologics and pharmaceuticals
  • Practical understanding of current GMP and GDP concepts and industry practices.
  • Experience managing and preparing for regulatory inspections and external audits.
  • Experience drafting content for regulatory submissions.
  • Experience interacting with regulatory authorities.

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.

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For Current Kite Pharma Employees and

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