For Current Kite Pharma Employees and
Please log onto your Internal Career Site to apply for this job
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.
- 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.