[Hiring] Value Stream Quality Manager @ImmunityBio, Inc.

Role Description

The Value Stream Quality Manager will be responsible for oversight of the product lifecycle of ImmunityBio’s products from a quality perspective. 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.

• 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.
• 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.
• Develop and foster positive relationships with CMO Quality and Manufacturing partners.
• 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 serve as Quality Person-In-Plant, as assigned.
• Support preparation for internal and external regulatory agency 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.

Qualifications

• 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 is required.
• Experience working with Contract Manufacturing Organizations (CMOs) is required.
• Experience in supporting both internal and external regulatory inspections is preferred.
• Lean, Six Sigma Greenbelt experience is required; certification is preferred.

Requirements

• Demonstrated knowledge of biologics cGMP manufacturing including recombinant protein and cell therapy cGMP manufacturing.
• Strong knowledge of biologics cGMP aseptic manufacturing is required.
• Advanced knowledge of relevant regulations and regulatory guidance.
• Able to prepare written communications with clarity and accuracy.
• Able to utilize strong problem-solving and analytical skills.
• 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.
• Able to operate in a fast-paced, multi-disciplinary industrial environment.
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner.
• Must be proficient in Microsoft Office (Excel, Word, Power Point, Visio) and Adobe Professional software.

Benefits

• 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.