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Sr QA Specialist - Quality Risk Management
On-site · Greenville, North Carolina, United States
Job Summary
Senior Quality Specialist in Quality Risk Management leading cross-functional GMP quality efforts in a pharmaceutical/biotech manufacturing environment. Provides technical leadership on GMP quality systems, conducts risk assessments, leads deviation investigations with root cause analysis, manages CAPAs for timely resolution, and supports regulatory inspections and audits. Collaborates with manufacturing, validation, and engineering to drive continuous improvement, contribute to data integrity initiatives and computer system validation, and ensure compliance with FDA/EMA/global GMP standards. Strong technical writing, communication, and project management skills with a focus on quality systems, change/document control, and risk management.
Required Qualifications
- Advanced degree with 6+ years of experience in quality assurance within GMP regulated pharmaceutical or biotech environments
- Strong experience in GMP regulated pharmaceutical/biotech environments
- Experience with investigations, CAPAs, change control, and document control
- Knowledge of FDA, EMA, and global GMP regulations (including 21 CFR Parts 210/211 and ICH guidelines)
- Data integrity and computer system validation experience preferred
- Experience hosting regulatory inspections and customer audits preferred
- Fluency in English; strong writing and communication skills
- Ability to work independently and collaboratively across diverse teams
- Experience with risk assessment methodologies and root cause analysis
- Strong analytical and problem-solving skills
- Experience with data integrity initiatives and computer system validation
- Preferred fields: Chemistry, Biology, Microbiology, Engineering, Validation
- Must be legally authorized to work in the United States without sponsorship
Additional Requirements
- Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
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