**For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) 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** Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish an inclusive line between that purpose and our day-to-day work. We are looking for motivated candidates to apply to our exciting Quality Assurance Documentation Supervisor role, in our brand-new Frederick MD facility. **_**Shift - Wednesday- Saturday, day shift (4x 10 hour days)**_** Responsibilities + Supervise on the floor Document Control and Label Control operations and oversee direct reports + Develop Document Control Team, provide the necessary training, ongoing coaching, discipline, recognition of direct staff, perform employee evaluation, and conduct regular one on one meetings. + Handle and mitigate on the floor issues as they occur ensuring adherence to Business, HR and Operational policies. + Ensure collaborative and positive working relationship with staff, supervisors and project lead + Maintain a document management system aligned with regulatory, quality, and Kite requirements. + Responsible for the administration of all documentation and records issuance and archival processes to support manufacturing process. + Provide consultancy and advice on approved procedures, standardization and requirements associated with the document management system. + Responsible for improving, executing and maintaining the document change control system. + Excellent understanding of quality systems and regulatory requirements. + Ensure accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems. + Collaborate with cross-functional departments to ensure timely implementation of document change controls and requests. + Issue effective documents including procedures, test methods, specifications, and batch documentation. + Assign lot related documentation and labels for manufacturing process. + Issue GMP documentation for implementation including qualification and test methods. + Support trackingand communication of site metrics to ownership + Identify and raise compliance gaps across the document management system. + Implement critical initiatives to improve the document management system. + Investigate deviations against the document management systemand develop effective corrective action plans. + Provide training to new staff on document management processes, procedures and label issuance. + Support audits (internal, external) as document management SME. Basic Qualifications: + Master’s Degree and at least 3 years’ experience in working within quality document management, quality engineering, quality assurance or quality systems OR + Bachelor’s Degree and at least 5 years’ experience in working within quality document management, quality engineering, quality assurance or quality systems OR + High School Degree and at least 9+ years’ experience in working within quality document management, quality engineering, quality assurance or quality systems. Preferred Qualifications: + Quality systems demonstrated thorough understanding in areas such as document management,document change control audits, batch record and label issuance. + Excellent knowledge of GMP, SOPs and quality system processes. + Excellent organizational skills + Proficient in MS Word, Excel, Power Point ,Adobe Pro, and electronic document management systems(Document Locator, Documentum, Veeva or equivalent). + Works on multiple assignments in collaboration with various department system owners. + Ability to communicate and work independently with scientific/technical personnel. + Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment. + Comfortable in a exciting environment with minimal direction and able to adjust workload based upon changing priorities. + Adaptable and comfortable in a collaborative and inclusive company environment The salary range for this position is: $99,705.00 - $129,030.00. 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 . **For jobs in the United States:** 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. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) 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. 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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job. **Change The World With Us** Everyone 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.