Value Stream Quality Manager

ImmunityBio, Inc.•El Segundo, CA

2d•Hybrid

About The Position

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.

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.
Lean, Six Sigma Greenbelt experience is required.
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.

Nice To Haves

Experience in supporting both internal and external regulatory inspections (e.g. FDA, EMA, MHRA) is preferred.
Certification is preferred.

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.

Benefits

This position is eligible for a discretionary bonus and equity award.
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
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