Quality Assurance Manager - RMOMAL

Responsibilities:
- Manage Quality Assurance programs to support regulatory and clinical efforts for FDA approval of advanced therapeutic products
- Act as QA representative in product development meetings, technology transfer, and scale-up activities
- Ensure data integrity (ALCOA+) across electronic systems and laboratory records
- Drive process optimization and efficiency improvements using Lean or Six Sigma
- Review documentation for accuracy, completeness, and compliance with GMP/QSR/Clinical Trial requirements
- Oversee supplier qualification, audits, and ongoing supplier performance monitoring
- Conduct internal and vendor audits; manage corrective actions and audit files; summarize data for annual product reports
- Lead QA oversight for deviations/failure investigations, change control, complaints, SOPs, and product quality reviews
- Lead risk assessments and CAPA programs to prevent recurrence
- Lead controlled document collaboration, review, and approval in the electronic document management system
- Establish and track KPIs; present trends and risk analysis to senior leadership
- Provide real-time review of clinical case data (may require after-hours review)
- Develop, implement, and maintain the laboratory QMS
- Review/write/update SOPs and reports
- Support validation protocols/reports with Operations/Quality/R&D; coordinate validation plans
- Develop and provide guidance on quality improvements
- Assist during FDA/other regulatory inspections
- Stay current on regenerative medicine and organ manufacturing technologies; perform other duties as assigned

Minimum Requirements:
- 8+ years in a GMP/QSR regulated environment with a Bachelor’s degree, or 6+ years with a Master’s degree
- Applied knowledge of GMPs/QSR and FDA guidelines
- Ability to interpret data for GMP/QSR/GCP compliance
- Ability to mentor/develop QA team members
- Experience reviewing/auditing medical and quality records
- Strong problem and risk analysis/assessments
- Excellent professional documentation skills and ability to communicate complex issues in writing
- Proficiency in MS Excel, PowerPoint, Word, and Outlook
- Ability to handle confidential company data

Preferred Qualifications:
- Expertise preparing for and managing FDA, EMA, and ISO audits
- Experience with IND/IDE/BLA submissions
- Experience with TrackWise and MasterControl (eDMS)
- Experience creating and implementing a QMS

Benefits:
- Medical/dental/vision/prescription coverage, wellness resources, 401(k) and ESPP, paid time off, paid parental leave, disability benefits, and more

Job Location:
- On-site at Durham, North Carolina (100% of the time)