Quality Systems Specialist I

Arbeitsbeschreibung

For Current Kite Pharma Employees and Contractors:

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

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

We are seeking a highly motivated individual who is a team player and has a mindset of growth, contribution, and continuous improvement to join us as a Quality Systems Specialist at Kite’s RDMC manufacturing site. The Quality Systems Specialist will ensure compliance with the Quality System’s procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

Responsibilities (Included but not limited to):

• Supports and maintains Document Control Activities: (Scanning, Archival, Retrieval, Logbook issuance, Production Issuance and Verification).
• Ensure Quality Systems conform to regulations and quality policies.
• Ensure adherence to ALCOA principles
• Support Quality Systems Governance for Quality Management Review.
• Serve as site Subject Matter Expert (SME) for defined Quality Systems.
• Develop, Coordinate, and lead Quality Systems governance & oversite meetings.
• Engage with key stake holders and site leaders to ensure timely closure of Quality Actions.
• Support quality assessments of internal operations to analyze compliance and assess risk.
• Support all facility internal audits and regulatory inspections as needed.
• Supports, develop and deliver technical and/or compliance training to Kite staff
• Develop, Track and communication of site metrics to management.
• Identify compliance and data integrity gaps across documentation quality systems.
• Generate and revise standard operating procedures and associated documents as needed.
• Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.

(This position may require flexibility and weekend/ holiday support)

Basic Qualifications:

• MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR
• BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality experience or experience in a GMP environment (Drug Substance or Drug Product) OR
• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ years of Quality experience or experience in a GMP environment (Drug Substance or Drug Product)

Preferred Qualifications:

• 2+ years of working within Quality Systems.
• Knowledge of Quality Systems and regulatory requirements.
• Thorough knowledge of GMPs (21 CRF Part 11/210/211).
• Understanding of Quality Systems, Deviation, CAPA, Change Control, Auditing practices/strategies.
• Works on multiple assignments in collaboration with various department system owners.
• Knowledge with aseptic manufacturing processes.
• Advanced Skills with MS Office applications Word, Excel, Access, PowerPoint as well as Adobe Acrobat.
• Experience in electronic Quality Management Systems, Document Management Systems, and Training Management Systems.
• Ability to communicate and work independently with scientific/technical personnel.
• Excellent interpersonal, verbal and written communication skills are meaningful in this collaborative work environment.
• Proactive, detail-oriented and comfortable in a exciting environment with minimal direction and able to adjust workload based upon changing priorities.

Does this sound like you? If so, apply today!

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The salary range for this position is: $78,455.00 - $101,530.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 ApplicantAccommodations@gilead.com for assistance.

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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:

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