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Senior Quality Specialist

1 month ago


Devens, Massachusetts, United States Bristol-Myers Squibb Full time
Job Summary

Bristol-Myers Squibb is seeking a Senior Quality Specialist to oversee the GMP/GDP Vendor and Material Management programs at our Devens Biologics site.

This role is responsible for the qualification and management of GMP/GDP vendors, including identification/assessment of new vendors, creation/revision of Quality agreements, and maintenance of the Approved Vendor List.

The successful candidate will also perform Quality assessment of supplier change notifications and drive actions through to completion using change management programs.

Additionally, this role will assist in discrepancy reporting, deviations, and CAPA associated with nonconforming materials or services provided by vendors.

Establishes and executes a process to ensure Quality oversight of on-site service vendors.

Key Responsibilities:

  • Qualify and manage GMP/GDP vendors
  • Perform Quality assessment of supplier change notifications
  • Drive actions through to completion using change management programs
  • Assist in discrepancy reporting, deviations, and CAPA
  • Establish and execute a process for Quality oversight of on-site service vendors

Requirements:

  • Bachelor's degree in science, engineering, biochemistry, or related discipline
  • Minimum 4 years of experience in a regulated environment, biopharmaceutical environment, or similar
  • Practical knowledge of US and EU cGMP regulations and guidance and ISO standards
  • Knowledge of electronic systems, including SAP, Veeva, and Syncade
  • Excellent written and oral communication skills

What We Offer:

  • A competitive salary and benefits package
  • Opportunities for professional growth and development
  • A collaborative and inclusive work environment
  • Recognition and rewards for outstanding performance

How to Apply:

Apply online at [insert link] or contact our HR department at [insert contact information].