Director, Commercial QCA

ImmunityBio•Culver City, CA

42d•$215,000 - $236,500•Onsite

About The Position

The Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials and finished products related to the commercial N-803 program and all other QCA programs that are advancing to the commercial stage.

Requirements

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
Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques.
Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections
Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously
Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities
In-depth knowledge in analytical method development and validation, and statistical quality control.
In-depth knowledge of GMPs, SOPs and pharmaceutical regulations.
Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
Understanding of GMPs and an ability to interpret and enforce regulatory requirements.
Ability to communicate professionally, knowledgeably, and efficiently with a wide range of employees and with all internal and external customers, both in writing and verbally.
Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Demonstrated track record in managing a staff and establishing a clear, strategic direction.
Ability to develop a high-morale organization with leaders, teams, and groups, and appropriately staff the QC department to meet business needs.
Ability to analyze and interpret complex, scientific documents, including problem solving.
Ability to multi-task and prioritize with excellent project management skills.

Nice To Haves

Experience with a start-up pharmaceutical company preferred
Understanding of cell therapy processes is desirable

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.

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