Manager, QA Patient Operations - Seattle Washington

Company: Disability Solutions
Location: Seattle, Washington
Posted On: 10/20/2024

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: . Position Summary: The primary objective of this position is to act as regional Quality Single Point of Contact. The Manager of QA Patient Operations will ensure a consistent approach to the operational oversight of Apheresis Network Onboarding and Maintenance as well as troubleshooting within this scope in support of clinical and commercial operations in the region. This position reports to the Associate Director of the Global Quality Patient Operations and Apheresis Regulatory Vigilance, CTDO. Duties & Responsibilities:

• Support development and review of Patient Operations processes and procedures in support of Scheduling, Apheresis Onboarding, Distribution and CDP On-Site Storage
• Support Quality Patient Operations liaison(s) to logistics, 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 patient materials, and chain of identity discrepancies
• Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the product lifecycle
• 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
• 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
• Support Key Performance Indicating metrics to ensure continuous improvement
• 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
• 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
• Support other Quality initiatives as directed by management Qualifications:
  • Minimum of Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering or closely related areas.
  • Good organizational skills, including ability to follow assignments through to completion
  • Provide advice, guidance, and support to the organization with regards to quality requirements
  • Good skills in leading, influencing, and negotiating
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement
  • Good knowledge and understanding 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, and to work with minimal supervision
  • Excellent verbal and written communication skill
  • Good skills in leading, influencing and negotiating with cross-functional team
  • This position does not require travelThe starting compensation for this job is a range from $ 97,000-$121,000 , 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. For more on benefits, please visit our BMS Careers site: 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 CareersWith 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 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 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 . Visit 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. More...

        

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