Manager/Senior Manager, Risk Management
Artiva Biotherapeutics - San Diego, CA
posted 2 days ago
About the position
This position is responsible for developing, managing, and leading the Risk Management Program at Artiva. The role involves identifying and evaluating risks within Artiva's cGMP processes, programs, products, and systems, and determining the appropriate risk tools for the analysis and evaluation of different risks. The candidate will develop risk-based approaches to Quality Systems such as deviations, non-conformances, and change controls, and create a Product Risk assessment for each Artiva product. Additionally, the role includes leading and facilitating the performance and documentation of cross-functional risk assessments for cGMP programs and functions, managing consultants and contractors as required, and writing risk management plans, reports, and FMEAs. The candidate will also track and manage risk control action items related to mitigation efforts, maintain databases and metrics, identify and communicate gaps, propose phase-appropriate solutions, support audits by regulatory or state agencies and partners, and follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures. Furthermore, the candidate will support other QA department needs as identified by management.
Responsibilities
- Develop and lead Artiva's Risk Management Program.
- Identify and evaluate risks within Artiva's cGMP processes, programs, products, and systems.
- Determine the appropriate risk tools for the analysis and evaluation of different risks.
- Develop risk-based approaches to Quality Systems such as deviations, non-conformances, and change controls.
- Create a Product Risk assessment for each Artiva product.
- Lead and facilitate the performance and documentation of cross-functional risk assessments for cGMP programs and functions.
- Manage consultants and contractors as required.
- Write risk management plans, reports, and FMEAs.
- Track and manage risk control action items related to mitigation efforts.
- Maintain databases and metrics.
- Identify and communicate gaps; propose phase-appropriate solutions.
- Support audits by regulatory or state agencies and partners.
- Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
- Support other QA department needs as identified by management.
Requirements
- Bachelor's degree or a combination of relevant education and applicable job experience.
- 8+ years' experience in an FDA-regulated industry and cGMP regulations.
- Must have expert-level experience in a Risk Management program.
Benefits
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Recognition program, Bonus.ly, where you can trade in points earned for things you want.
