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Manager Quality Engineering Amsterdam Netherlands,  

Gilead (company)

Posted on : 13 August 2018

Project Description

for current gilead employees and contractors: please log onto your internal Career site to apply for this job. job description we are one company at multiple locations. while it all started in santa monica, we now have several locations and facilities. we are continuing to expand our corporate headquarters and our el segundo Manufacturing center is state-of-the-art. we continue to expand our global footprint and now have a european location in london and amsterdam. currently we are in the process of building a new Manufacturing site in hoofddorp (near schiphol). we are seeking highly motivated individuals to support our efforts to set up the Manufacturing site in this exciting new area of Cancer immunotherapy and delivering t-cell immunotherapies to patients in the near future from this new site. in this role you will be working as a manager quality Engineering. responsibilities (include but are not limited to): manage qe personnel, includes organizing and prioritizing group tasks, performing Training, and writing performance reviews. create quality Documentation and provides input for sops for kite pharma commensurate with industry standards. help carryout continuous improvement to the Manufacturing process and quality by design initiatives. develop Validation master plans based on FDA/ispe guidance for all processes and methods related to our lead product and follow on products. further develop, implement, and continuously improve the Qualification and Validation system. use a risk based approach to support Qualification and Validation. plan, schedule, and carryout Project Management of technical projects with cross-functional teams. further develop, implement and continuously improve the kite pharma Risk Management tools for justification of specifications and processes. work closely with functional areas to identify areas of risk and strategies to reduce or eliminate those risks. further develop, implement and continuously improve the kite Quality System, Change Control system including capa, and product complaint management system. author technical investigation reports, including Root Cause Analysis and capa. further develop, implement and continuously improve kite pharma Statistical tools for process, method and supplier monitoring. provide independent audit support for cmos, cros, and critical suppliers. provide audit, inspection and Due Diligence support. provide technical response and expertise (written and verbal) during audits, inspections and Due Diligence on kite pharma quality related topics and systems. work with various 360 stakeholders including product and development teams, Clinical teams, functional Manufacturing teams, and suppliers, as well as the corporate quality department.   requirements: at least 8 years in a technical role in quality Engineering, Manufacturing, analytical Testing or Engineering including management of technical personnel. experience with t Cell biology, Immunology and immunotherapy and related equipment is preferred. experienced in all stages of Validation for systems and process. excellent knowledge of computerized system Validation approaches based on gamp 5. certified in, or has demonstrated knowledge of, Six Sigma. excellent knowledge of cGMP and cgxp Manufacturing and regulatory agency regulations and requirements for biologics, Pharmaceuticals and devices. audit and inspection experience. experience in Risk Management, Change Control and capa systems. following safety requirements and ensure they are met at every point in the Manufacturing facility. accepting temporary responsibilities outside of initial job description. using verbal and written Communication and technical presentation skills to collaborative in the work environment. comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities. the primary location of the position is amsterdam, netherlands, but job requirements may involve some travel based on business priorities.   more information? applictions can be submitted using the ‘apply” button. would you like to know more before you apply? please contact me, janne bruntink - talent acquisition specialist, via: or call our recruitment desk: +3120 237 45 91. 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 for assistance. for more information about equal employment opportunity protections, please view the ‘eeo is the law’ poster. notice: Employee polygraph protection act your rights under the family and medical leave act pay transparency nondiscrimination provision 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 jobs in france: conformément à la loi « informatique et libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par gilead et pourront être transmises aux organismes sociaux. par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. vous pouvez exercer ce droit en contactant: for current gilead employees and contractors: please log onto your internal Career site to apply for this job.


Amsterdam - Kite

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