Value Stream Quality Manager
ImmunityBio, Inc.
4 hours ago
Remote friendly (California, United States)
United States
Operations
Position Summary
- Responsible for oversight of the product lifecycle of ImmunityBio products from a quality perspective (from new product introduction through commercialization), ensuring quality standards and regulatory/organizational expectations are met.
- Supports GMP production activities both internally and at external partners/CMOs for clinical and commercial products via quality control process development/implementation, data analysis, cross-functional collaboration, and continuous improvement.
Essential Functions
- Deploy Lean, Six Sigma methodology and tools to manage value stream flow to customers.
- Manage product lifecycle end-to-end to ensure compliance with global GMP requirements.
- Own, lead and/or manage quality programs supporting Value Stream Quality.
- Identify continuous improvement activities and implement changes to enhance Value Stream Quality management.
- Ensure adherence to global industry regulations and quality standards.
- Lead strategic quality planning for new product introduction, lifecycle phase transitions, and major product change controls.
- Provide quality oversight for risk assessments, deviations, and CAPAs; conduct product impact assessments and review/approve deviations.
- Review and approve product specifications and product-related protocols/reports.
- Collaborate with internal/external partners to meet needs compliantly.
- Review external program investigations with cross-functional teams; ensure robust investigation, root cause identification, and corrective/preventive action.
- Build relationships with CMO Quality/Manufacturing partners; hold them accountable to business needs.
- Participate in CMO team meetings and escalate quality/compliance issues to senior leadership.
- Participate in site audits; serve as Quality Person-In-Plant as assigned.
- Support regulatory agency inspections and serve as SME during regulatory GMP inspections.
- Maintain training compliance and train others as assigned.
- Create/draft/revise SOPs, work instructions, and controlled documents.
Education & Experience (Required)
- Bachelor’s degree in engineering, biological science, chemistry, or related science.
- 7+ years in clinical and/or commercial pharmaceutical/biopharmaceutical industry.
- Minimum 5 years in Quality Assurance/Quality Control.
- Advanced understanding of quality management systems and all phases of the product lifecycle.
- Experience with Contract Manufacturing Organizations (CMOs).
- Lean, Six Sigma Greenbelt experience (certification preferred).
Skills/Knowledge (Required unless noted)
- Demonstrated biologics cGMP manufacturing knowledge (recombinant protein and cell therapy).
- Strong knowledge of biologics cGMP aseptic manufacturing.
- Ability to prepare accurate written communications and critically review batch production documents; apply quality risk management principles.
- Strong analytical/problem-solving skills with independent decision-making.
- Effective written/verbal communication with leadership and cross-functional teams.
- Ability to plan, organize, prioritize, and manage multiple priorities in a fast-paced environment.
- Proficient in Microsoft Office (Excel, Word, PowerPoint, Visio) and Adobe Professional.
Preferred
- Experience supporting internal/external regulatory inspections (FDA, EMA, MHRA).
- Demonstrated experience working with recombinant protein and cell therapy (as applicable to aseptic manufacturing).
Working Environment
- On-site or remote based on geographic location; Monday–Friday with possible off-hours/second shift/weekend flexibility (manager approved). Ability to gown and access manufacturing areas; exposure to in-lab environment; lift up to 20 pounds.
Benefits (if eligible)
- Medical, dental and vision plan options.
- Health and financial wellness programs; Employer Assistance Program (EAP).
- Company paid/voluntary life/AD&D, short-term and long-term disability.
- Healthcare and dependent care flexible spending accounts.
- 401(k) with company match; 529 education savings program.
- Paid time off (PTO) includes 11 holidays; Unlimited PTO for exempt employees; Non-exempt PTO/vacation described in posting.
- Responsible for oversight of the product lifecycle of ImmunityBio products from a quality perspective (from new product introduction through commercialization), ensuring quality standards and regulatory/organizational expectations are met.
- Supports GMP production activities both internally and at external partners/CMOs for clinical and commercial products via quality control process development/implementation, data analysis, cross-functional collaboration, and continuous improvement.
Essential Functions
- Deploy Lean, Six Sigma methodology and tools to manage value stream flow to customers.
- Manage product lifecycle end-to-end to ensure compliance with global GMP requirements.
- Own, lead and/or manage quality programs supporting Value Stream Quality.
- Identify continuous improvement activities and implement changes to enhance Value Stream Quality management.
- Ensure adherence to global industry regulations and quality standards.
- Lead strategic quality planning for new product introduction, lifecycle phase transitions, and major product change controls.
- Provide quality oversight for risk assessments, deviations, and CAPAs; conduct product impact assessments and review/approve deviations.
- Review and approve product specifications and product-related protocols/reports.
- Collaborate with internal/external partners to meet needs compliantly.
- Review external program investigations with cross-functional teams; ensure robust investigation, root cause identification, and corrective/preventive action.
- Build relationships with CMO Quality/Manufacturing partners; hold them accountable to business needs.
- Participate in CMO team meetings and escalate quality/compliance issues to senior leadership.
- Participate in site audits; serve as Quality Person-In-Plant as assigned.
- Support regulatory agency inspections and serve as SME during regulatory GMP inspections.
- Maintain training compliance and train others as assigned.
- Create/draft/revise SOPs, work instructions, and controlled documents.
Education & Experience (Required)
- Bachelor’s degree in engineering, biological science, chemistry, or related science.
- 7+ years in clinical and/or commercial pharmaceutical/biopharmaceutical industry.
- Minimum 5 years in Quality Assurance/Quality Control.
- Advanced understanding of quality management systems and all phases of the product lifecycle.
- Experience with Contract Manufacturing Organizations (CMOs).
- Lean, Six Sigma Greenbelt experience (certification preferred).
Skills/Knowledge (Required unless noted)
- Demonstrated biologics cGMP manufacturing knowledge (recombinant protein and cell therapy).
- Strong knowledge of biologics cGMP aseptic manufacturing.
- Ability to prepare accurate written communications and critically review batch production documents; apply quality risk management principles.
- Strong analytical/problem-solving skills with independent decision-making.
- Effective written/verbal communication with leadership and cross-functional teams.
- Ability to plan, organize, prioritize, and manage multiple priorities in a fast-paced environment.
- Proficient in Microsoft Office (Excel, Word, PowerPoint, Visio) and Adobe Professional.
Preferred
- Experience supporting internal/external regulatory inspections (FDA, EMA, MHRA).
- Demonstrated experience working with recombinant protein and cell therapy (as applicable to aseptic manufacturing).
Working Environment
- On-site or remote based on geographic location; Monday–Friday with possible off-hours/second shift/weekend flexibility (manager approved). Ability to gown and access manufacturing areas; exposure to in-lab environment; lift up to 20 pounds.
Benefits (if eligible)
- Medical, dental and vision plan options.
- Health and financial wellness programs; Employer Assistance Program (EAP).
- Company paid/voluntary life/AD&D, short-term and long-term disability.
- Healthcare and dependent care flexible spending accounts.
- 401(k) with company match; 529 education savings program.
- Paid time off (PTO) includes 11 holidays; Unlimited PTO for exempt employees; Non-exempt PTO/vacation described in posting.