Gilead Sciences, Inc. (Senior) Manager, Quality Assurance, Site Qualification (m/w/d) in Madrid, Spain
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!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld) to apply for this job
(Senior) Manager, Quality Assurance, Site Qualification (m/w/d)
We are seeking highly motivated individuals to join us as QA (Sr.) Manager Site Qualification. You will be supporting our efforts in the exciting area of CAR-T cell therapy. You will work cross functionally and as part of a global team to assist with the qualification and monitoring program for hospitals performing apheresis and treatment (ACTS) who are already working or intend to work with Kite CAR-T cell products. In addition, as required, you will be responsible for performing and addressing quality systems aspects related to qualification and monitoring of apheresis centers and treatment site (ACTS).
Perform new site qualifications (including audits and trainings) and monitoring of authorized ACTS.
Facilitate the review and approval of Quality Agreements, between Kite and the apheresis centers and treatment sites
Collaborate with cross-functional departments to ensure timely implementation of quality records.
Provide support to Kite CAPAs, OOS, deviations, change records, and product complaints. Interact with ACE (Australia, Canada and Europe) regional quality, local affiliates and hospitals as it pertains to issue resolution and or general questions.
Works cross-functionally within Kite (Supply Chain, Process Sciences, Manufacturing, Regulatory Affairs, Manufacturing QA and QC teams and Kite corporate quality) and externally, to assure compliance and strong relationships with the hospitals.
Assist with resolution of ACTS issues and discrepancies, and the investigations to resolve the issues.
Assist on the quality aspects of the implementation of an Apheresis Collection Application System in the ACE region as needed.
Collaborate with our Gilead affiliates in the routine management of the ACTS relationships.
Support inspection readiness plans and interact with regulatory agencies during inspections on ACTS-related and quality matters, as needed.
Liaise Kite quality teams to develop, implement and maintain ACE and global quality systems.
Assist as needed on the activation and maintenance of ACTS in Kite GMP IT systems.
Perform other duties as assigned.
We are seeking a highly motivated individual which likes to join our international Site Qualification Team. The ideal candidate for this position is flexible, has great communication skills and feels comfortable in a fast-paced environment.
Bachelor’s degree or higher in biological sciences, nursing, medical technologist, or related field
Knowledge of GMP and quality assurance
Proficiency in English
Experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
Ability to travel nationally and internationally up to 40%
Medical center or pharmaceutical auditing experience
Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers
Proficiency level in German or more languages is a plus
Previous experience presenting and responding to regulatory agency or certification audits,
Previous experience with managing supply and quality contracts with hospitals
Proficient in MS Word, Excel, and Power Point and quality management systems like Agile/Trackwise.
Relevant experience working in multicultural and cross functional teams.
- European affiliate, Kite Hoofddorp or remote based
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 .
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld) to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.