Sr. Specialist QA, QMS
Bristol Myers SquibbAbout the role
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.
Position: QA Principal Specialist, QRM/QMS
Location: Phoenix, Arizona
Key Responsibilities
- Provide sitewide oversight of status and compliance of records in the Quality Risk Management Program.
- Ensures reports are available for record statuses.
- Develop and maintain tracking and status monitoring dashboards/tools for QRM records.
- Designs and enforces processes to ensure department-level ownership and accountability of QRM records.
- Utilizes site/department Tier processes to communicate QRM requirements and metrics.
- Supports the site and Global Quality through the Local Process Owner (LPO) network.
- Functions as an LPO for all quality risk management processes.
- Supports QRM enhancements in coordination with global teams.
- Maintains tools provided by global teams such as FMEA, Process Mapping, etc.
- Owns and manages processes designed to complement managing QRM in the Quality System.
- Build, educate, and manage a sustainable site QRM training program.
- Manages the use of meeting norms, templates for QRM records, and other QRM tools.
- Brand and incorporate a QRM culture throughout the facility.
- Create a site communication strategy for QRM.
- Provides information needed for other quality processes.
- Provides trending/metrics as requested for use in Quality Council.
- Performs trending as needed on a department-level, process-level basis as needed.
- Performs QRM trending per designated frequencies, including authoring and communicating summary reports.
- Performs all other tasks as assigned.
Qualifications & Experience:
- Bachelor’s degree is required.
- 6 years relevant work experience required, preferably in Pharmaceuticals.
- 2 years of project management experience preferred.
- An equivalent combination of education and experience may substitute.
- Advanced knowledge of Quality Risk Management and the applicable QRM tools.
- Advanced knowledge of cGMPs.
- Advanced written and verbal communication skills.
- Advanced ability to influence, coach and motivate others in accomplishing goals and meeting metrics.
- Intermediate knowledge of international regulatory requirements (FDA, EU, MHRA, etc.).
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
#LI-Onsite
BMSBL
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
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 rem
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