Senior Specialist Ii, Quality Assurance Compliance

For Current Kite Pharma Employees and Contractors:

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

At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

We are seeking a highly motivated individual to join us as a Sr. Specialist II, QA Compliance in the Corporate Quality and Compliance department. In this role, you 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):

• Ability to travel up to 50%.
• Provide support for all quality-related issues.
• Assist with the planning and execution of External and Internal Audits.
• Work closely with Kite manufacturing sites in areas of GMP compliance.
• Prepare accurate and timely reports according to established procedures.
• Ensure that the audit program is up to date by tracking and reviewing Audit Master Schedule.
• Create and sustain a culture that is based on continuous improvement, with ownership of applicable Quality Policies driving compliance across Tech Ops
• Maintain accurate records of audit findings and activities.
• Assist in the scheduling, performance, and tracking of Kite Audits in accordance with regulatory and company requirements.
• Assure tracking of key performance metrics and participate in periodic reviews to ensure suitability and effectiveness of the audit program.
• 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. Author and own global policies to execute requirements across Tech Ops.
• 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.
• Perform other duties as assigned.
• Execute audits to verify compliance with global Good Manufacturing Practices regulations, product CMC license/dossier filings, and corporate requirements.
• Identify opportunities for improvement, as well as identification and implementation of appropriate actions.
• Perform analyses of audit findings to identify any trends among noncompliance items.
• Provides training and competency
• Support and assist other compliance team members with regulatory commitments, BPDRs, regulatory intelligence, MRB, inspection readiness activities and quality escalations.
• Support or act as lead auditor at manufacturing site internal audit(s)
• Assure communication of compliance concerns, regulatory agency expectations and industry trends as part of on-going education and training for GMP compliance.
• Responsible for review of audit reports prior to distribution.
• Act as internal compliance consultant and/or provide other resources with expertise.

Basic Qualifications:

• High School Degree in life sciences or engineering discipline and 12 years of experience in regulated industry, biologics or biotech.
• MS/MA Degree in life sciences or engineering discipline and 6 years of experience in regulated industry, biologics or biotech.
• BS/BA Degree in life sciences or engineering discipline and 8 years of experience in regulated industry, biologics or biotech.

Preferred Qualifications:

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

#QCQA123

#IND123

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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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 protected] for assistance.

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For Current Kite Pharma Employees and Contractors:

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