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Manager, QC Systems and Services - Bothell Washington
Company: Disability Solutions Location: Bothell, Washington
Posted On: 05/08/2024
Working with UsChallenging. 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 .At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. 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.Shift Available: - Monday - Friday, Hybrid Day Shift (8 a.m. - 5 p.m. PST)Responsibilities:
- Responsible for owning a process within the QC Systems organization. West Coast Site Lead would be responsible for CELabs west coast operations.
- Subject matter expert \ in a system process, supporting system deployment across CTO.
- Anticipate and perform complex troubleshooting and problem solving independently.
- Perform data verification, data review and review of GMP documentation for multiple systems (general and complex) and/or products.
- Drives/Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- May represent the department in regulatory inspections (internal and external audits).
- Train and mentor others on multiple QC system modules, processes and procedures.
- Cross trained on business and technical aspects of the QC Systems organization.
- Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
- Master Data Delivery within the timelines set forth by the SLA/Business
- Responsible for Site Issue and Risk Management with respect to CTO systems under the Network QC umbrella.
- Site Coordination of CELabs Go-live activities and business workstreams.Knowledge & Skills:
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Advanced knowledge of LIMS, ELN and/or Cellular Therapy business process highly preferred.Basic Requirements:
- Bachelor's degree required. An equivalent combination of education and experience will be considered.
- 3-5 years of Project Management experience.
- 3-5 years of Systems Management experience (including systems deployment).
- 3 years of Technical Writing skills.
- 3 years of Master Data experience.
- 3 years of Cell Therapy experience.
- Strong communication skills.Preferred Requirements:
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