Quality Assurance Manager

4 weeks ago

Seattle, Washington, United States Bristol-Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Quality Assurance Manager to join our team in Seattle, Washington.

About the Role

The Quality Assurance Manager will be responsible for ensuring a consistent approach to the operational oversight of Apheresis Network Onboarding and Maintenance. This includes troubleshooting within this scope in support of clinical and commercial operations in the region. The successful candidate will report to the Associate Director of the Global Quality Patient Operations and Apheresis Regulatory Vigilance, CTDO.

Key Responsibilities
  • Support the 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.
  • 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.
  • 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.
Requirements
  • 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 teams.
What We Offer

Bristol-Myers Squibb offers a competitive salary range of $97,000-$121,000, plus incentive cash and stock opportunities (based on eligibility). We also offer a comprehensive benefits package, including medical, pharmacy, dental, and vision care, as well as wellbeing support, financial well-being resources, and a 401(K) plan.

We are an equal opportunity employer and welcome applications from qualified candidates. If you are passionate about quality and committed to transforming patients' lives through science, we encourage you to apply for this exciting opportunity.

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