Associate Director, Operations Training and Investigations
Legend Biotech
6 hours ago
On-site
Raritan, NJ
Operations
Role Overview
The Associate Director, Operations Training and Investigations will provide strategic direction and leadership for the investigations management system and the Operations training “door-to-floor” program. Oversees the Training and Investigations team in collaboration with Operations and Quality management to support personalized cell therapy production through safe and compliant operations per cGMP.
Key Responsibilities
- Lead, direct, coach, and develop a holistic training program for plant functions/personnel supporting daily clinical production and commercial readiness for a CAR-T product.
- Manage the training team to plan, coordinate, prepare, and deploy training curricula.
- Serve as subject matter expert for Compliance & Training systems.
- Maintain and report quality training metrics.
- Prepare information for internal and external audits.
- Address recurring deviations and improve investigation quality.
- Ensure productivity, timeliness, and quality of investigations and CAPA implementation.
- Allocate resources (personnel, budget, technology) as SPOC/integrator for the investigations management system.
- Collaborate cross-functionally on deviation management, investigation quality, and batch disposition timeliness.
- Provide training and mentorship to improve deviation management capabilities.
- Monitor KPIs (investigation quality, timeliness, closure rates, overdue records, deviation recurrence) and proactively address gaps.
Requirements
- Bachelor’s degree in a scientific or related field; advanced degree preferred.
- 10+ years of experience, including 3+ years in deviation investigations management and 5 years in an aseptic manufacturing facility; preferably in training/system applications, quality systems, or learning management systems.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing; knowledge of Good Tissue Practices.
- Strong understanding of GMP, root cause analysis, and CAPA.
- Proven leadership and team management; excellent communication and stakeholder engagement.
- Demonstrated continuous improvement.
- Training/mentoring experience preferred.
- Must be willing to work onsite; occasional flexibility based on business needs.
Benefits (for permanent full-time employees)
- Medical, dental, and vision insurance; 401(k) with company match (vests day one).
- 8 weeks paid parental leave after 3 months employment.
- Paid time off including vacation, personal, sick, floating holidays, and 11 company holidays.
- Additional voluntary benefits: flexible spending/HSAs, life/AD&D, short- and long-term disability, legal assistance, and supplemental plans; commuter benefits, family planning/care resources, well-being initiatives, and peer-to-peer recognition.
Base Pay
- $163,468–$214,551 USD (base).
The Associate Director, Operations Training and Investigations will provide strategic direction and leadership for the investigations management system and the Operations training “door-to-floor” program. Oversees the Training and Investigations team in collaboration with Operations and Quality management to support personalized cell therapy production through safe and compliant operations per cGMP.
Key Responsibilities
- Lead, direct, coach, and develop a holistic training program for plant functions/personnel supporting daily clinical production and commercial readiness for a CAR-T product.
- Manage the training team to plan, coordinate, prepare, and deploy training curricula.
- Serve as subject matter expert for Compliance & Training systems.
- Maintain and report quality training metrics.
- Prepare information for internal and external audits.
- Address recurring deviations and improve investigation quality.
- Ensure productivity, timeliness, and quality of investigations and CAPA implementation.
- Allocate resources (personnel, budget, technology) as SPOC/integrator for the investigations management system.
- Collaborate cross-functionally on deviation management, investigation quality, and batch disposition timeliness.
- Provide training and mentorship to improve deviation management capabilities.
- Monitor KPIs (investigation quality, timeliness, closure rates, overdue records, deviation recurrence) and proactively address gaps.
Requirements
- Bachelor’s degree in a scientific or related field; advanced degree preferred.
- 10+ years of experience, including 3+ years in deviation investigations management and 5 years in an aseptic manufacturing facility; preferably in training/system applications, quality systems, or learning management systems.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing; knowledge of Good Tissue Practices.
- Strong understanding of GMP, root cause analysis, and CAPA.
- Proven leadership and team management; excellent communication and stakeholder engagement.
- Demonstrated continuous improvement.
- Training/mentoring experience preferred.
- Must be willing to work onsite; occasional flexibility based on business needs.
Benefits (for permanent full-time employees)
- Medical, dental, and vision insurance; 401(k) with company match (vests day one).
- 8 weeks paid parental leave after 3 months employment.
- Paid time off including vacation, personal, sick, floating holidays, and 11 company holidays.
- Additional voluntary benefits: flexible spending/HSAs, life/AD&D, short- and long-term disability, legal assistance, and supplemental plans; commuter benefits, family planning/care resources, well-being initiatives, and peer-to-peer recognition.
Base Pay
- $163,468–$214,551 USD (base).