Senior Quality Program Specialist

Lonza Group

Walkersville, MD, US
Base: $95,000 to $153,000 annually; bonus: perform...
Onsite
7 years qa experience in regulated environments
Bachelor's degree in scientific or engineering discipline
Expertise in cgmp, iso standards, and fda regulations
Lonza Group is seeking a Senior Quality Program Specialist for their Walkersville, MD office, responsible for ensuring compliance with ISO and cGMP quality systems. The ideal candidate will have extensive experience in Quality Assurance within regulated environments, alongside strong project management and technical writing skills

Job Summary

  • The Senior Quality Program Specialist serves as a Quality Assurance Subject Matter Expert ensuring compliance with ISO and cGMP requirements.
  • This role involves providing independent quality oversight, leading audits, and approving critical documents like CAPAs, deviations, and change controls.
  • Candidates will benefit from a comprehensive package including performance bonuses, medical insurance, 401(k) matching, and paid time off.

Matching Summary

Match Score: 85

Lonza Group is seeking a Senior Quality Program Specialist for their Walkersville, MD office, responsible for ensuring compliance with ISO and cGMP quality systems. The ideal candidate will have extensive experience in Quality Assurance within regulated environments, alongside strong project management and technical writing skills.

Salary

Base: $95,000 to $153,000 annually; Bonus: Performance-related bonus available; Benefits: Medical, dental, vision, 401(k), life, disability, PTO

Skills & Requirements

Must-have

  • 7 years QA experience in regulated environments
  • Bachelor's degree in scientific or engineering discipline
  • Expertise in cGMP, ISO standards, and FDA regulations
  • Computer system validation and equipment qualification skills
  • Proficiency with TrackWise QMS and Document Management Systems

Nice-to-have

  • Experience interacting with FDA or regulatory agencies
  • Strong technical writing and documentation skills
  • Ability to lead and mentor team members
  • Proactive mindset focused on continuous improvement
  • Project planning and execution capabilities

Key Requirements

  • Minimum 7 years of relevant work experience
  • Bachelor's degree required in science or engineering
  • Extensive knowledge of cGMPs and FDA regulations

Work Rights

Not specified

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