United States - Maryland - Frederick, United States of America
Onsite
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:
The ability to work on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
Exercises judgment to determine appropriate action with minimal supervision.
Ability to handle pressure and fast decision making.
Responsibilities (included but not limited to):
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.
Knowledge:
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.
Basic Qualifications:
7+ years of relevant experience in a GMP environment related field and a BS/BA.
OR
5+ years of relevant experience and a MS.
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 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.
Please apply via the Internal Career Opportunities portal in Workday.