Gilead Sciences, Inc. Hiring for Quality Assurance Operations Supervisor at Frederick, Maryland Full Time

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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.

Job Description

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.

We are seeking a highly motivated individual to join us as QA Operations Supervisor at our commercial manufacturing site in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Must be proficient in Quality Systems, particularly associated with Operations, Batch Record Review, Change Control and Exception Management / CAPA.

Note: Role is for a 4 days x10hrs, Wednesday to Saturday or Sunday to Wednesday – Second shift (starting from 5:00pm to 3:30am).

Responsibilities include (but are not limited to):

• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative. This role will require working

• Coordinate and facilitate Quality Assurance related production and production related activities, including:

• Approval of electronic batch records and manufacturing labels.

• Assessment and closure of discrepancies, deviations and change controls requests.

• Assessment and closure of laboratory investigations.

• Timely assessment and closure of batch and material hold events.

• Communicate lot issues to management.

• Review of batch manufacturing and testing documentation for timely delivery of final product.

• Management of shift responsible for supporting QA operations for the site

• Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.

• Support development of SOPs and review/approve SOPs to ensure quality objectives are met

• Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.

• Review and approve manufacturing production records.

• Compile and verify all batch related documents into a final product lot disposition package.

• Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.

• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

• Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.

• Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.

• Review and disposition raw materials, components, and labels for GMP use.

• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

• Manage and participate in internal, external and regulatory inspections and audits at the site.

• Perform other duties as required.

Basic Qualifications:

• Master’s Degree and 3+ years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR

• Bachelor’s Degree and 5+ years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR

• High School Degree and 9+ years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

Preferred Qualifications:

• Experience in leading and managing personnel

• Ability to work (10 hours/day, 4 days a week) including one weekend day

• Must be proficient in Quality Systems, particularly associated with Operations, Batch Records, Change Control and Exception Management/CAPA.

• Working knowledge of quality systems and ability to apply GMP’s in conformance to U.S. and EU standards.

• Experience with approving test method qualification/validation protocols and reports.

• Strong knowledge of GMP, SOPs and quality systems.

• Ability to effectively negotiate and build collaboration amongst direct reports and supporting teams.

• Strong interpersonal, verbal and written communication skills.

• Experience with laboratory and manufacturing investigations, deviations, and CAPA.

• Experience with change control practices and strategies.

• General knowledge of aseptic manufacturing processes.

• Knowledge of equipment, facility, and utility IQ/OQ/PQ.

• Proficient in MS Word, Excel, Power Point and other applications.

• Ability to communicate and work independently with scientific/technical personnel.

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.

Dos this sound like you? If so, please apply today!

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 [email protected] for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, and Australia employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.