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Manager, Material Quality Management

Employer
ImmunityBio, Inc
Location
El Segundo, CA
Start date
Nov 26, 2022

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Job Details

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

POSITION SUMMARY

The Quality Manager supports the Material Quality Management Program at ImmunityBio that ensures compliance of all GMP materials with phase appropriate Global regulatory requirements, cGMP’s, and ImmunityBio requirements and expectations. This position interacts cross-functionally across the ImmunityBio organization and multiple manufacturing sites.

The successful candidate is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in in their work scheduling to meet the demands of a multi-product clinical phase bio-pharmaceutical company that is transitioning to the commercial phase.

ESSENTIAL FUNCTIONS

  • Assist in development and roll out of a compliant and effective Material Quality Management Program.
  • Execute procedures for the Material Quality Management Program, including:
  • Global material introduction
  • Global material life cycle
  • Global material specification creation and master specification templates
  • Establish routine and qualification testing requirements for materials
  • Maintain Global material specifications
  • Maintain Global approved item list
  • Provide support and participates as the Subject Matter Expert for the Material Quality Management program during audits and inspections.
  • Identify and provide leadership for continuous improvement initiatives for ImmunityBio related to the Material Quality Management programs.
  • Coach, mentor and develop staff to ensure the team is able to effectively and efficiently meet the needs of the organization in a manner consistent with the company mission and values and other standards of conduct.
  • Cross-training with Supplier Quality Management (i.e. supplier qualification and maintenance activities).
  • May conduct other Material Quality related duties as needed, such as;
  • Participate in cross-functional team meetings to resolve non-conformance and CAPA issues.
  • Perform supplier evaluations and audits as technical SME.
  • Perform material-related activities associated with Change Controls
  • Contribute to SCARs
  • Contribute to Supplier Change Notifications assessments
  • Participate in internal audits.
  • May conduct other Quality related duties, as assigned.
  • Technical subject matter expert (SME) for supplier qualification and material management/ supply chain to ensure a product driven, technically sound, compliant, and sustainable supply for all ImmunityBio materials and components
  • Perform criticality and suitability assessment for all GMP material applied to ImmunityBio, and ImmunityBio sponsored CMO production.
  • Execute material qualification strategies and protocols for material changes.
  • Partner with QC to coordinate routine and qualification material testing per requirements
  • Support holistic program evaluations related to material risk in support of CMC submissions; including but not limited to;
    • Extractable & Leachable studies
    • Container closure studies
    • Accelerated aging studies for stability

EDUCATION/EXPERIENCE REQUIREMENT

  • Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7+ years of experience, or equivalent experience in a GMP regulated Biologics or Pharmaceutical environment.
  • Minimum 2 years of direct management experience.
  • Experience in 21 CFR 210/211, 21 CFR 600/610, and 2001/83/EC
  • Experience in Material Quality/ Management/ Testing
  • Experience in clinical and commercial phase pharmaceutical environment (preferred).
  • Experience with Contract Manufacturing Organizations (preferred).

REQUIRED CORE COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

  • Able to prepare written communications with clarity and accuracy. Must have strong authorship and be able to critically review responses and partner on corrective actions/commitments consistent with quality and regulatory compliance expectations.
  • Strong problem-solving skills with demonstrated attention to detail.
  • Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Ability to work both independently with minimal supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
  • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
  • Demonstrated ability to interface with senior leaders and cross-functional teams.
  • Ability to gown and gain entry to manufacturing areas.
  • Proficient in computerized systems. Must be proficient in Microsoft Office (Excel, Word, Access, PowerPoint, Visio) and Adobe Professional software.
  • Flexibility in working schedule, i.e., off hours, second shift, weekend and travel work as required. Travel may be up to 10%.

*All hires are based upon successful completion and passage of a background check

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Company

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

Stock Symbol: IBRX

Find Us
Website
Phone
844-696-5235
Location
9920 Jefferson Blvd.
Culver City
CA
90232
United States
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