Sr Associate Iii, Quality Assurance Inspection Management

Bilbao HR

Research Triangle Park, NC, United States
Base: $111,000.00-$149,000.00; bonus/equity: cash ...
Manage regulatory and partner inspections
Process regulatory requests
Quality oversight on regulatory responses
As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility

Job Summary

  • As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility.
  • This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment to quality and excellence.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility.

Salary

Base: $111,000.00-$149,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, 401(k) with match, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • Manage regulatory and partner inspections
  • Process regulatory requests
  • Quality oversight on regulatory responses
  • Develop and deliver GxP training
  • Knowledge of FDA/EMEA regulations

Nice-to-have

  • Keen eye for detail
  • Proactive approach to quality
  • Thrive in collaborative settings
  • Autonomous decision-making
  • Experience with partner audits

Key Requirements

  • Bachelor’s degree in scientific/technical discipline or Associate's Degree with 9+ years related experience
  • Minimum 7 years of experience in pharma, biotech or medical device regulated/GMP industry
  • Demonstrated leadership abilities
  • Ability to communicate with senior management
  • Proficient understanding of quality systems

Work Rights

Not specified

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