Value Stream Quality Manager

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.
Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

The Value Stream Quality Manager will be responsible for oversight of the product lifecycle of ImmunityBio’s products from a quality perspective.  To meet the demands of a multi-product clinical phase bio-pharmaceutical company that is transitioning from clinical to commercial phase with several products, this position works cross-functionally with Process Sciences, Manufacturing, Quality Control and Regulatory Affairs and will support the product lifecycle from new product introduction to commercialization ensuring that products meet established quality standards, are fit for purpose, and align with regulatory and organization expectations.  This role will support GMP production activities, both internally at ImmunityBio and at external parters or CMOs (Contract Manufacturing Organizations), for both clinical and commercial products by developing and implementing quality control processes, analyzing data to identify issues, collaborating with cross-functional teams, and driving continuous improvement initiatives to maintain phase appropriate compliance to regulations.

Essential Functions

• 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.

Education & Experience

• 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.
• Lean, Six Sigma Greenbelt experience. Certification is preferred.

Knowledge, Skills, & Abilities

• 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. Must have strong authorship and be able to critically review batch production documents, interpret results, evaluate product impact, and generate technical conclusions consistent with Quality risk management principles.
• Able to utilize strong problem solving and analytical skills to make detailed oriented decisions independently with limited supervision.
• Demonstrated ability 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.

Working Environment / Physical Environment

• This position works on-site in El Segundo
• 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.
• Ability to gown and gain entry to manufacturing areas.
• Exposure to onsite in-lab environment.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

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

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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 •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.