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

KEY REQUIREMENTS

Degree and Qualifications

• University graduate (science degree, preferred)

Experience - Responsibility and minimum number of years in regulated function.

• Experience as a CQV, QA, and/or QC representative within Pharmaceutical/Drug Device Manufacturing (API, Sterile, Non-Sterile or Biological products) or Medical Device Manufacturing or Laboratory environment.
• Working knowledge in the following:
• Process Control Systems
• Process Equipment and Utilities
• Laboratory Equipment and Instrumentation
• Packaging and Labeling Equipment
• Environmental Monitoring Systems
• Supply Chain Systems
• Demonstrated knowledge and experience in cGMP regulations.
• Effective Interpersonal and organizational skills.
• Demonstrated leadership skills.
• Proficiency with MS Office Suite

LI-Hybrid

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.

Perform specific quality related functions to ensure facilities, utilities, equipment (including instruments and computerized systems) used in the manufacture, processing, testing, inspection, packaging, labeling, holding, storage, release, and distribution of Active Pharmaceutical Ingredient (API) or Investigational Medicinal Product (IMP) intended for investigational and registrational purposes are commissioned, qualified, validated, and maintained in compliance with applicable cGMP regulations and industry standards

Key Responsibilities

• Perform independent review and approval of initial commissioning, qualification, and validation lifestyle documents and subsequent changes.
• Review and approval of periodic re-qualification assessments.
• Review and approval of retirement and decommissioning plans, protocols and summary reports.
• Review and approval of documentation related to change control.
• Review documents related to Quality Systems such as SOPs.
• Review Validation Master Plans (i.e. site, department and functional area/building)
• Provide instruction and guidance on quality issues during regulatory agency inspections, deviations, and CAPA discussions.
• Participate in the Quality Agreement process for Contract Service Providers.
• Provide reports to management related to timely CAPA implementation or other issues, as requested.
• Participate in Vendor/Contractors Qualification activities, as requested.
• If in a supervisory role, determines and coordinates the assignment of tasks to be carried out by the assigned Associates/Specialists.
• Bring to the attention of management, any information relating to the impact of legislation on the functions of the department, system deviations