Director, Commercial QCA jobs in United States
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ImmunityBio, Inc. · 6 days ago

Director, Commercial QCA

ImmunityBio, Inc. is a commercial-stage biotechnology company developing innovative therapies aimed at enhancing the human immune system to fight cancer. The Director, Commercial QCA is responsible for overseeing quality control programs, ensuring product reliability and compliance with regulations, and managing the Analytical Quality Control staff.

Health CareHealth DiagnosticsTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability)
Transfer, review, and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies
Ownership and oversight of all assay trending programs
Design and implement methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability. Design and implement strategies to transfer methods into QCA groups
Ensure QCA decisions align with Quality System, GMP and regulatory requirements
Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation
Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance
Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Qualification

Quality Control AnalyticalAssay qualificationValidationGMP knowledgeAnalytical method developmentRegulatory inspections experienceLeadership skillsCommunication skillsOrganizational skillsProblem-solving skillsProject management skills

Required

Bachelor's degree in biology, chemistry, or other scientific related field with 15 years of related quality experience with 8+ years at the management level required; or
Master's degree in biology, chemistry, or other scientific related field with 10 years of related quality experience with 8+ years at the management level required; or
Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience with 8+ years at the management level required
Extensive experience with assay qualification, validation, and transfer activities required
Experience for a FDA PLI, Surveillance, or other inspection, with an acceptable outcome required

Preferred

Experience with a start-up pharmaceutical company preferred

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
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Company

ImmunityBio, Inc.

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ImmunityBio, Inc.

H1B Sponsorship

ImmunityBio, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (6)
2022 (7)
2021 (1)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$1.36B
Key Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M

Leadership Team

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Enrique Diloné
Chief Technology Officer
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Leonard Sender
COO
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Company data provided by crunchbase