Value Stream Quality Manager

About the role

The Value Stream Quality Manager will oversee the product lifecycle of ImmunityBio's products from a quality perspective. This role supports the product lifecycle from new product introduction to commercialization, ensuring compliance with global GMP requirements.

Responsibilities

• Deploy Lean, Six Sigma methodology and tools to manage the value stream flow of ImmunityBio’s product to customers.
• Manage product lifecycle from end to end to ensure compliance with global GMP requirements for ImmunityBio products portfolio.
• Own, lead and/or manage quality programs supporting Value Stream Quality activities and responsibilities.
• Identify continuous improvement activities and implement changes to enhance the overall Value Stream Quality management and oversight of product lifecycle.
• Ensure adherence to global industry regulations and quality standards.
• Lead the strategic quality planning process for new product introduction, lifecycle phase transitions and major product change controls for process and specifications.
• Provide quality oversight for product-related risk assessments, deviations and CAPAs.
• Provide product impact assessments and reviews/approves ImmunityBio deviations related to internal/external products.
• Review and approve product specifications and product related protocols and reports for internal and external programs.
• Collaborate with internal and external partners to meet the needs of the organization in a compliant manner.
• Review external program investigations with cross-function team ensuring robust investigation and product impact assessment, appropriate root cause identification and implementation of appropriate corrective and preventative actions.
• Develop and foster positive relationships with CMO Quality and Manufacturing partners and hold them accountable to business needs.
• Participate in CMO team meetings and escalate quality and compliance issues to Senior Leadership Teams at ImmunityBio.
• Participate in internal and external site audits and serves as Quality Person-In-Plant, as assigned.
• Support preparation for internal and external regulatory agency inspections and participate as a subject matter expert during regulatory GMP inspections.
• Maintain compliance with all assigned training requirements and train others as assigned.
• Create, draft and/or revise SOPs, work Instructions, and other controlled document types, as assigned.
• Perform ad-hoc and cross-functional duties and/or projects to support business needs and provide developmental opportunities.

Requirements

• Bachelor’s degree in engineering, biological science, chemistry, or related science field is required.
• 7+ years of experience in the clinical and/or commercial pharmaceutical / biopharmaceutical industry is required.
• Minimum 5 years of direct experience in Quality Assurance / Quality Control is required.
• Advanced understanding of and experience working with quality management systems and across all phases of the product lifecycle (early phase through commercial) is required.
• Experience working with Contract Manufacturing Organizations (CMOs) is required.
• Experience in supporting both internal and external regulatory inspections (e.g. FDA, EMA, MHRA) is preferred.
• Leverage Lean, Six Sigma Greenbelt experience. Certification is preferred.

Qualifications

• Demonstrated knowledge of biologics cGMP manufacturing including recombinant protein and cell therapy cGMP manufacturing.
• Strong knowledge of biologics cGMP aseptic manufacturing (required), including recombinant protein and cell therapy (preferred).
• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues and team members.
• Able to prepare written communications with clarity and accuracy.
• Able to utilize strong problem solving and analytical skills to make detailed oriented decisions independently with limited supervision.
• Able to effectively communicate (written and verbal) and interface with leadership, peers and cross-functional team members.
• Able to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Able to operate in a fast-paced, multi-disciplinary industrial environment and while managing multiple priorities.
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, and project timelines.
• Must be proficient in Microsoft Office (Excel, Word, Power Point, Visio) and Adobe Professional software.

Skills

• Knowledge of biologics cGMP manufacturing including recombinant protein and cell therapy cGMP manufacturing.
• Strong knowledge of biologics cGMP aseptic manufacturing (required), including recombinant protein and cell therapy (preferred).
• Advanced knowledge of relevant regulations and regulatory guidance.
• Ability to prepare written communications with clarity and accuracy.
• Strong problem-solving and analytical skills.
• Effective communication (written and verbal) and interface with leadership, peers and cross-functional team members.
• Ability to plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Adaptable to dynamic conditions, and project timelines.
• Proficient in Microsoft Office (Excel, Word, Power Point, Visio) and Adobe Professional software.

Benefits

ImmunityBio offers a competitive total rewards benefits package, including:

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

Pay

$155,000 (entry-level qualifications) to $170,500 (highly experienced) annually

Schedule

Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. Flexibility in working schedule, i.e., off-hours, second shift, and weekends.