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:- REQUIREMENTSReview batch-related documentation and ensure resolution of issues to release product.
- Perform comprehensive quality review of batches for disposition.
- Ensure process control measures are in place and followed in product manufacturing.
- Ensure all product-related Deviations are initiated, investigated and resolved.
- Ensure that associated CAPAs are initiated and resolved, as needed.
- Generate and update procedures, forms and other documents.
- As assigned, manage and provide QA oversight for other processes, including training, warehouse /inventory, redose, new product introductions, etc.
- Maintain production (finite ), disposition, and team schedules Represent Disposition or QA Ops at plant and multi-site scheduling meetings.
- Provide QA representation at multi-site disposition meetings
- Provide QA representation on projects and at team meetings
- Maintain metrics related to product disposition in support of the Management Review and for continuous improvement.
- Support and participate in inspections and audits.
- Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
QUALIFICATIONS:
Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, or a related scientific discipline. Minimum 3-4 years of experience in a regulated pharmaceutical, biotechnology, cell therapy, medical device, or GMP manufacturing environment. Working knowledge of cGMP regulations, FDA requirements, and applicable quality systems. Experience reviewing and approving GMP documentation, including batch records, deviations, CAPAs, change controls, and investigations. Strong attention to detail with the ability to identify compliance risks and quality concerns. Demonstrated ability to make quality decisions based on data, procedures, and regulatory requirements. Effective written and verbal communication skills with the ability to interact across Quality, Manufacturing, Supply Chain, and Technical Operations. Proficiency in electronic quality management systems, document management systems, and Microsoft Office applications. PREFERRED QUALIFICATIONS2-3 years of QA Operations, batch disposition, product release, or manufacturing quality experience in biotechnology, cell therapy, or pharmaceutical manufacturing. Experience performing lot disposition and product release activities in a GMP environment. Knowledge of cell therapy manufacturing processes and associated quality requirements. Experience with electronic batch records, Veeva Vault, MES, SAP, or similar quality/manufacturing systems. Strong understanding of deviation management, risk assessments, change control, and data integrity principles. Ability to manage multiple priorities in a fast-paced manufacturing environment while maintaining compliance. Experience supporting internal and external audits and regulatory inspections. Demonstrated ability to influence cross-functional teams and drive quality-focused decision making. The salary range for this position is: $92,820.00 - $120,120.00.
Benefits:
Benefits include company-sponsored medical, dental, vision, and life insurance plans*.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. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeingEligible 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.For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by 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. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Change The World With UsEveryone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. 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 the beginning.
