Associate Director, Quality Assurance - Regenerative Organ Manufacturing; RMOMAL

Responsibilities

• Provide strategic and operational leadership for Quality Assurance for the RMOMAL regenerative organ manufacturing program (Pre-IND through IND-enabling milestones, subsequent BLA submission, and commercialization).
• Develop QA strategy and translate it into operational plans for the RMOMAL QA/QC organization.
• Initiate and lead phase-appropriate QMS build-out and IND-readiness initiatives.
• Serve as QA representative for IND-enabling gap assessments (CMC/GMP, regulatory strategy, clinical readiness, quality systems); support Pre-IND meetings and RMAT designation.
• Own planning, staffing, budgeting, and expenses for RMOMAL Quality Assurance.
• Lead and develop the RMOMAL QA/QC team (QA Manager; QA Specialists, QC Supervisor, QC Analyst).
• Own and continuously improve the phase-appropriate Quality Management System (SOPs, forms, training, document hierarchy).
• Ensure compliance with data integrity (ALCOA+) and applicable regulatory frameworks (21 CFR Parts 600–680, 1271, 11; ICH Q9/Q10).
• Oversee deviation/failure investigations, CAPA, change control, complaints, and product quality reviews; track KPIs and risk.
• Review regulated documentation for accuracy, completeness, and compliance with GMP/cGTP/QSR/Clinical Trial requirements.
• Support validation protocol/report development (process validation, MCB generation, aseptic process simulation) and QA dispositions.
• Lead controlled document review/approval in the electronic document management system.
• Negotiate/manage Quality Agreements and Manufacturing/Supply Agreements with external partners (including 21 CFR Part 1271 cell banking).
• Oversee partner performance via audits, supplier qualification, and monitoring; lead/support internal and vendor/CMO audits and corrective actions.
• Assist during FDA/other regulatory inspections; interpret direction and respond to mitigate issues.
• Stay current on regenerative medicine/tissue engineering/cell therapy/organ manufacturing technologies and regulatory trends.

• Bachelor’s degree (technical/scientific); 12+ years related experience (or 10+ years with a Master’s).
• 6+ years people management experience.
• Experience contributing to IND/BLA (or similar) for cell/tissue-based regenerative medicine or organ manufacturing.
• Applied cGMP/cGTP/QSR/FDA knowledge; ability to apply GxP to novel/emerging modalities.
• Experience with MCB generation, aseptic process simulation (APS), or cell banking QA oversight.
• Proven experience building/implementing a QMS in Pre-IND or early clinical-stage environments.
• Experience negotiating/managing Quality Agreements and Manufacturing/Supply Agreements with CMOs/test labs.
• Strong risk assessment, analytical judgment, and problem-solving.
• Ability to mentor/coach and resolve conflicts; strong change management.
• Excellent technical/professional documentation and cross-functional communication.
• Expertise preparing for/managing FDA, EMA, and ISO audits.

• Master’s degree (technical/scientific).
• Proficiency: MS Excel, PowerPoint, Word, Outlook; AI prompt engineering/tools.
• Experience with donor eligibility/biovigilance/HCT/P (21 CFR Part 1271).
• Experience with Track Wise, Master Control (eDMS); working knowledge of LIMS.
• Ability to lead organizational change and apply Lean/Six Sigma.

• Medical/dental/vision/prescription coverage
• wellness resources
• 401(k) and ESPP
• paid time off
• paid parental leave
• disability benefits.