Job Details
Manager, Global QA Patient Operations
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 Summary:
The Manager, Global QA Patient Operations, will collaborate with and support the Cell Therapy Development Operations (CTDO) Patient Operations department. The Manager, Global QA Patient Operations will ensure a consistent and global approach to operational oversight of Apheresis Network Onboarding and Maintenance as well as process and logistical troubleshooting within this scope in support of clinical and commercial operations.
Key Responsibilities:
Support development, review and approval of Global Patient Operations processes and procedures in support of Scheduling, Apheresis Onboarding, Distribution and CDP On-Site Storage
Support Quality Pt Ops liaison(s) to manufacturing process/personnel and associated apheresis and final drug product troubleshooting; provide real-time quality event support including but not limited to: decision making for apheresis collection, shipping to MFG sites, and finished drug product shipping to sites of care.
Serve on project teams by providing quality assurance guidance and input regarding quality systems application and execution in support of project activities.
Provide Quality representation and direction to Patient Operations and technical teams, as required.
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 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) system general support, data configuration approvals, SOP review and approval
Quality Operations and Systems Support including deviation management, change management, complaints, CAPA, compliance guidance (issue management)
Support Key Performance Indicating metrics to ensure continuous improvement
Review and negotiate apheresis site Quality Agreements, as required
Support North America team for on-site product storage assessments
Interface with regional clinical specialists and Commercial 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.
Qualifications & Experience:
Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering or closely related field
Minimum of 5 years’ experience in a FDA-regulated industry
Strong organizational skills, including ability to follow assignments through to completion
Strong skills in leading, influencing, and negotiating
Strong 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
Preferred Qualifications:
Experience in Quality Assurance or Quality Operations supporting cellular therapy
Experience with Commercial products
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
Strong written and verbal communication skills
Detail-oriented with expertise in problem solving and solid decision-making abilities
Ability to work in a fast-paced environment
Able to work effectively with global partners in Patient Operations, QA Patient Operations and with US BMS Manufacturing sites
Working Conditions
Equipment Usage During Work Period: Computer 70%; Phone and Electronic Devices 30%.
Sitting at a computer terminal for an extended period.
Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
Requirement to work in a conference room / meeting environment for moderate periods of time.
Occasional periods in labs or production area, requiring some level of gowning.
Light to moderate lifting.
Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
Moderate noise i.e. business office with computers, phone, and printers.
BMSCART
#LI-Hybrid
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 rate takes into account characteristics of the job, such as required skills and the where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
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.
COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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