QA Risk Management Sr Engineer
$145,000–$165,000 year
On-site · Fishers, Indiana, United States
Job Summary
Lead the quality risk management program at INCOG BioPharma Services as the QA risk management SME. Develop, implement, and maintain risk management policies, procedures, and tools in alignment with ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, 820, and EU GMP Annex 20. Establish and manage the site-wide Quality Risk Register; provide oversight across deviations, investigations, CAPAs, change controls, engineering projects, validation activities, and device assembly operations. Prepare risk management metrics and reports for Quality System Management Review; facilitate risk assessment workshops and training; support regulatory inspections and client audits; ensure integration with CCS and the QMS. Partner with Manufacturing, Engineering, Validation, and Project Management to embed risk-based thinking into daily operations and continuous improvement.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Chemistry, or related scientific discipline; advanced degree preferred
- Minimum of 7 years of experience in quality assurance, quality risk management, or related function within GMP-regulated pharmaceutical/biotech/medical device manufacturing
- Experience developing and implementing quality risk management programs, including risk policies, SOPs, and risk assessment tools
- Strong working knowledge of ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, 820, and EU GMP Annex 20
- Hands-on experience with FMEA, FTA, HACCP, PHA
- Experience in aseptic/sterile injectable drug product manufacturing or parenteral fill-finish operations
- Excellent written and verbal communication skills
- ASQ CQE/CRE or ISO 13485 certifications (preferred)
- Experience at CDMO and familiarity with ISPE PDA ASTM E2500 guidance
- Regulatory inspections experience (FDA/EMA)
- Contamination Control Strategy knowledge and CCS integration
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