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Manager, Qc Systems And Services

Company

Bristol Myers Squibb

Address Bothell, WA, United States
Employment type FULL_TIME
Salary
Category Pharmaceutical Manufacturing
Expires 2023-10-11
Posted at 8 months ago
Job Description
Working with Us


Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.


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 with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us.


Purpose of Position


This position is responsible for the harmonization, life-cycle management and continuous improvement of all GMP quality system elements within the Laboratory Systems technology platform including but not limited to LabWare. In this role, the incumbent will serve as the primary representative for site system deployment related activities and cross-functional partnerships and collaborations. This is a highly visible role with Cellular Therapy Global responsibility and cross functional influence that has a high degree of impact on departmental performance, broad quality initiatives, Quality Control, Quality Operations and the Business.


Education


  • Advanced degree preferred.
  • Bachelor’s degree or equivalent required, preferably in Science.


Experience


  • 4-6 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
  • Demonstrated experience in systems deployment.
  • Demonstrated ability to establish processes between multiple groups within Cell Therapy


Knowledge, Skills, And Abilities


  • Demonstrated technical writing skills.
  • Advanced knowledge of LIMS, ELN and/or Cellular Therapy business process highly preferred.
  • High problem-solving ability/mentality, technically adept and logical.
  • Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
  • Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.


Roles And Responsibilities


  • Perform data verification, data review and review of GMP documentation for multiple systems (general and complex) and/or products.
  • Responsible for owning a process within the QC Systems organization. West Coast Site Lead would be responsible for CELabs west coast operations.
  • Master Data Delivery within the timelines set forth by the SLA/Business
  • Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
  • May represent the department in regulatory inspections (internal and external audits).
  • Responsible for Site Issue and Risk Management with respect to CTO systems under the Network QC umbrella.
  • Train and mentor others on multiple QC system modules, processes and procedures.
  • Site Coordination of CELabs Go-live activities and business workstreams.
  • Subject matter expert \ in a system process, supporting system deployment across CTO.
  • Drives/Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
  • Cross trained on business and technical aspects of the QC Systems organization.
  • Anticipate and perform complex troubleshooting and problem solving independently.


The starting compensation for this job is a range from $92,000 - $115,000 , plus incentive cash and stock opportunities (based on eligibility).


The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.


For more on benefits, please visit our BMS Careers site.


Eligibility for specific benefits listed in our careers site may vary based on the job and location.


Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.


If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.


Uniquely Interesting Work, Life-changing Careers


With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.


On-site Protocol


Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.


BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.


BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.


BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.


Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.