Bristol Myers Squibb-posted 12 days ago
$93,910 - $121,528/Yr
Full-time • Manager
New Brunswick, NJ

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. 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.

  • Reviews all batch and test documentation associated with investigational medicinal products (IMPs), APIs, raw materials and packaging components and releases those found in compliance into SAP and Quality management system.
  • Schedules and plans work against timelines.
  • Supports in the investigation of non-conformances and quality incidents.
  • Resolves and documents deviations or problems pertaining to the audit of documents.
  • Tracks and trends deviation investigations and CAPAs.
  • Rejects APIs, raw materials, packaging components, and bulk products that fail compliance to GMP regulations and BMS specifications.
  • Ensures records relating to the manufacturing/packaging/testing of IMPs are submitted to the documentation center.
  • Reviews and approves documents related to Quality Systems such as master batch records, validation protocols/reports, change control, or SOP/WI/OIs.
  • Conducts GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees.
  • Participates in Vendor/Contractors Qualification activities as assigned.
  • Issues reports to the supervisor as requested.
  • Supports management in monitoring document tracking and manpower resource allocations.
  • Coordinates scheduling/review of records as requested.
  • Participates in the monitoring program for product quality checks, media fills and visual inspection program.
  • Supports internal and/or external audits as required.
  • Performs other tasks as requested by the supervisor.
  • Acts as authorized delegate in the absence of the Quality Operations Senior Manager.
  • A M.S. with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a B.S. with 7-9 years of relevant experience.
  • 2-4 years experience in a regulated function.
  • Experience in a R&D environment is an asset.
  • Strong knowledge of pharmaceutical processing techniques.
  • In-depth knowledge of GMP regulations.
  • Strong interpersonal and organizational skills.
  • Demonstrated leadership skills.
  • Computer literacy: Microsoft Office and SAP environment, Quality management system, Veeva, PDLIMS, and other systems as required.
  • Experience in a R&D environment.
  • Demonstrated initiative to clarify unclear situations in the presence of documentation irregularities.
  • Ability to prioritize when handling multiple work assignments and deadlines.
  • 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.
  • Work-life programs including paid national holidays, Global Shutdown Days, up to 120 hours of paid vacation, and sick time off.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits.
  • Tuition reimbursement and a recognition program.
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