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Manager, Quality Systems, Cell Therapy
4 months ago
**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.
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.
Position Summary:
The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations, and Risk Management, per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities.
Key Responsibilities:
- Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
- Ensure quality system deliverables are robust and adequately address requirements and risks, by providing oversight and rubric reviews, as applicable
- Support the administration and maintenance of quality systems such as CAPA, Investigations, and Risk Management, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation, as needed.
- Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.
- Lead meetings and represent function at cross functional and network meetings.
- Identify improvement opportunities and drive team continuous improvement goals and projects
- Support internal and external inspections.
- Maintain compliance with assigned learning plan.
- Support integration of newer team members and provide guidance and coaching to users of the electronic QMS, CAPA, and Investigations quality systems, as required.
- Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across teams. Build & maintain strong relationships with partner functions.
Qualifications & Experience:
- Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
- 6+ years professional experience. 5+ years in a regulated industry, preferably with 2+ years of quality system experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
- Demonstrated proficiency with electronic system and databases
- Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed change control actions
- Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
- Ability to work in a fast-paced team environment and changing priorities
- Detail oriented and task focused with ability to meet deadlines and prioritize work
- Confident in making decisions for complex issues and able to recognize Quality issues and solve problems
BMSCART
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS cares about your well-being and the
