Manager QA, Patient Operations CAR-T

21.01.2020 | Employee | 100%

Manager QA, Patient Operations CAR-T

Share This Page Manager QA, Patient Operations CAR-T Qlty Assurance Methods Boudry, , Switzerland Full time R1520474_EN 1/20/2020 4:03:32 PM Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Juno Therapeutics/Celgene is seeking a Manager within the Global Cell Therapy Quality Unit to partner with and support the Global Patient Operations department (including Patient Scheduling & Cell Logistics, Apheresis Network Operations, Patient Planning & Reporting, and Business Systems & Integrations). This team’s goals include ensuring a consistent and global approach to operational oversight of Apheresis Network Onboarding and Maintenance as well as cellular and logistical troubleshooting within this scope. Job Description Support development, review and approval of global processes and procedures in support of Scheduling, Apheresis Onboarding, Distribution and CDP On-Site Storage. Serve as a key contributor on project teams by providing quality assurance guidance and input regarding quality systems application and execution in support of project activities. Provide real-time quality event support, to include support of European operations. Provide Quality representation and direction to Patient Operations and technical teams, as required. Quality Operations and Systems Support including deviation management, change management, complaints, CAPA, compliance guidance (issue management). Creation and management of Key Performance Indicating metrics to ensure continuous improvement. Review and negotiate apheresis site Quality Agreements, as required. Assist with compliance and other regulatory inspections and in developing remediation efforts and responses. Recognize opportunity for improvement, driving CAPA and/or change control. Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the lifecycle of autologous cell therapies. Collaborate with Rest of World teams in order to ensure consistent application of global procedures and processes. Provide Quality review and approval of training materials, internal and external procedures, apheresis accounts (JAMS), risk assessments, and commercial readiness documentation in support of Apheresis Network onboarding and maintenance. Support Customer Experience Playbook and Call Trees. Provide Global Patient Services (GPS) general support, data configuration approvals, SOP review and approval. Support European team for on-site product storage assessments. Interface with regional clinical specialists and Launch Excellence Managers. Assist with compliance and other regulatory inspections and in developing remediation efforts and responses. Recognize opportunity for improvement, driving CAPA and/or change control. Model effective and constructive communication behaviors and interactions with technical departments both orally and in writing. Support other Quality initiatives as directed by management. Required Qualifications Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering or closely related areas. 5 - 10 years EU GMP regulated industry experience with a minimum of 5 years’ experience in quality assurance, quality control, and compliance. Strong organizational skills, including ability to follow assignments through to completion. Advanced skills in leading, influencing, and negotiating. Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues. Independent decision making capability and ability to think conceptually and understand impact of decisions. Excellent verbal and written communication skills. Ability to work in cross functional teams. Fluent in English. Preferred Qualifications Experience within the Cellular Therapeutics environment. Experience with Commercial products. Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition. Ability to prioritize and successfully manage complex and competing projects. Detail-oriented with expertise in problem solving and solid decision making abilities. Ability to work in a fast paced environment. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Working with Us By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Come Meet Our Team Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. For US Applicants Only Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please . If you'd like more information on your EEO rights under the law, please click here: and Follow Us Powered by © 2018 Bristol-Myers Squibb Company

21.01.2020
Employee, 100%

Contact

Celgene Management Sàrl

No recruitment agencies please

Bristol Myers Squibb

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896

Bristol Myers Squibb

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896
Salary

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