Frederick, Maryland, United States · On-site
$124k–$160k/yr
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…
Skills: GMP, GLP, CAPA, Six Sigma, DMAIC
Santa Monica, California, United States · On-site
$154k–$199k/yr
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…
Skills: Analytical Method Development, Compendial Testing, Process Impurities Analysis, Immunoassays, ELISA
Frederick, Maryland, United States · On-site
$124k–$160k/yr
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…
Skills: GMP, GLP, Quality Assurance, CAPA, Change Control
Frederick, Maryland, United States · On-site
$100k–$129k/yr
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…
Skills: Materials Management, People Leadership, cGMP Compliance, Inventory Control, Warehouse Operations
El Segundo, California, United States · Hybrid
$115k–$164k/yr
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…
Skills: Clinical Trial Management, FDA Regulations, ICH GCP Guidelines, Vendor Management, Study Start-up
El Segundo, California, United States · Hybrid
$115k–$164k/yr
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…
Skills: Clinical Trial Management, Study Start-up, FDA Regulations, ICH GCP Guidelines, Vendor Management
United States · Remote OK
$206k–$266k/yr
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…
Skills: Strategic Account Management, Contract Negotiation, Market Access, Cross-functional Collaboration, Customer Engagement
Hoofddorp, North Holland, Netherlands · On-site
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…
Skills: Quality Compliance, Regulatory Inspections, Audit Readiness, Self-Inspection Programs, cGMP
United States · Remote OK
$93k–$120k/yr
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…
Skills: Case Management, Care Coordination, Customer Experience, Tele-management, Cross-functional Collaboration
El Segundo, California, United States · Hybrid
$154k–$199k/yr
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…
Skills: Product Management, Salesforce, Agile Methodology, Stakeholder Management, Roadmap Development
Santa Monica, California, United States · On-site
$56k–$72k/yr
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…
Skills: Supply Chain Management, Warehouse Operations, GMP Compliance, Inventory Management, ERP Transactions
United States · Remote OK
$206k–$266k/yr
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…
Skills: Market Access, Payer Relations, Strategic Account Management, CAR-T Reimbursement, Contract Negotiation
United States · On-site
$221k–$286k/yr
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…
Skills: Scientific Exchange, Relationship Management, Clinical Trial Support, Medical Presentations, Hematology/Oncology Expertise
El Segundo, California, United States · Hybrid
$133k–$172k/yr
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…
Skills: CMC Regulatory Filings, Module 3 Development, Global Regulatory Strategy, Cross-functional Collaboration, Health Authority Interaction
Foster City, California, United States · Hybrid
$206k–$293k/yr
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…
Skills: Trade Strategy, Distribution Model Design, 3PL Governance, Channel Optimization, Market Access
Foster City, California, United States · On-site
$196k–$253k/yr
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…
Skills: Payer Strategy, Value Platform Development, Market Access, HEOR, CAR-T Reimbursement
El Segundo, California, United States · Hybrid
$255k–$331k/yr
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…
Skills: Strategic Leadership, Medical Affairs Strategy, Evidence Generation, Launch Planning, Stakeholder Engagement
Santa Monica, California, United States · Hybrid
$124k–$160k/yr
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…
Skills: Vendor Management, Clinical Logistics, 3PL Management, Purchase Order Management, Drug Procurement
El Segundo, California, United States · Hybrid
$115k–$149k/yr
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…
Skills: Clinical Trial Management, Vendor Management, CRO Oversight, Regulatory Compliance, GCP
Hoofddorp, North Holland, Netherlands · On-site
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…
Skills: GMP, GLP, Deviation Management, CAPA Management, Root Cause Investigation
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The role involves managing the daily workflow of the QA Tech services team and ensuring compliance with GMP and GLP standards. Key duties include leading investigations, managing CAPAs, and providing QA oversight for deviations and change controls.
Requires a BS/BA with 7+ years of GMP experience or an MS with 5+ years of relevant experience. Candidates must be proficient in QA principles, risk management tools, and possess strong analytical and communication skills.
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.
This position requires:
Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
Exercises judgment within established procedures and practices to determine appropriate action with minimal supervision.
Act as a mentor to QA junior staff.
Manages the daily workflow of the QA Tech services team.
Develops and Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Conducts or acts as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products, and performs QA review and approval of complex deviations and CAPAs.
Provide QA oversight to deviations, OOS investigations, Laboratory Investigations, CAPAs, Effectiveness Checks and Change Controls.
Knowledgeable in Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
Support the development of Risk Management documents using tools such Failure Mode Effects Analysis (FMEA), etc.
Uses/Develops KPI’s to identify and solve problems within the quality process.
Identifies deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems.
Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
Assists with external audits/inspection processes as required, and acts as an SME for QA procedures and processes during inspections and audits, supporting implementation of corrective actions as agreed.
Interfaces with external stakeholders to address documentation and compliance issues.
Leads QA projects or contributes to cross functional projects using Lean concepts. Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences. Provides support to incoming escalations from various stakeholders, ensuring all immediate actions are taken and a path forward established.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed. Additional duties as assigned.
Proficient in GMPs and/or GLPs.
Proficient in application of QA principles, concepts, industry practices, and standards.
Demonstrates ability to effectively manage multiple projects/priorities.
Has proven analytical and conceptual skills.
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates excellent verbal communication, technical writing and interpersonal skills.
Demonstrates working knowledge and good proficiency in Microsoft Office applications.
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
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.
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 [email protected] 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.
Please apply via the Internal Career Opportunities portal in Workday.
At Kite, a Gilead Company, our singular focus is achieving cures with cell therapy. Our goal is to bring the promise of cell therapy to as many eligible patients as possible who may benefit. Since 2009, Kite has been at the forefront of cancer immunotherapy. Today, we are proud to be the leader in engineered T cell therapy for hematologic malignancies, but we recognize that this is just the beginning. Patients are at the heart of our focus on the cure, which is why we are committed to pursuing cell therapy as a transformative treatment option for as many patients as possible who may benefit. Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly line. Cell therapy specialists at our manufacturing facilities reengineer a patient’s own immune cells to attack and fight their cancer cells — one patient at a time. That sense of connection to the people we serve motivates us daily at Kite. Our corporate headquarters are located in Santa Monica, California, and we have dedicated cell therapy manufacturing facilities in California, Maryland and the Netherlands. If you’re passionate about bringing the curative potential of cell therapy to more eligible patients, let’s talk. See our community guidelines: http://bit.ly/2DznMNw
Offices: 2400 Broadway, Santa Monica, California 90404, US · 2355 Utah Avenue, El Segundo, CA 90245, US · 1800 Stewart St, Santa Monica, California 90404, US · 4010 Ocean Ranch Blvd, Oceanside, California 92056, US · 930 Clopper Rd, Gaithersburg, Maryland 20878, US
At Kite, a Gilead Company, our singular focus is achieving cures with cell therapy. Our goal is to bring the promise of cell therapy to as many eligible patients as possible who may benefit. Since 2009, Kite has been at the forefront of cancer immunotherapy. Today, we are proud to be the leader in engineered T cell therapy for hematologic malignancies, but we recognize that this is just the beginning. Patients are at the heart of our focus on the cure, which is why we are committed to pursuing cell therapy as a transformative treatment option for as many patients as possible who may benefit. Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly line. Cell therapy specialists at our manufacturing facilities reengineer a patient’s own immune cells to attack and fight their cancer cells — one patient at a time. That sense of connection to the people we serve motivates us daily at Kite. Our corporate headquarters are located in Santa Monica, California, and we have dedicated cell therapy manufacturing facilities in California, Maryland and the Netherlands. If you’re passionate about bringing the curative potential of cell therapy to more eligible patients, let’s talk. See our community guidelines: http://bit.ly/2DznMNw
Offices: 2400 Broadway, Santa Monica, California 90404, US · 2355 Utah Avenue, El Segundo, CA 90245, US · 1800 Stewart St, Santa Monica, California 90404, US · 4010 Ocean Ranch Blvd, Oceanside, California 92056, US · 930 Clopper Rd, Gaithersburg, Maryland 20878, US
