Manager, Validation

About the role

The Manager, Validation is responsible for leading the validation team to meet company objectives. Key responsibilities include:

• Leading and supporting validation projects
• Overseeing commissioning, cleaning validation, process validation, and equipment qualifications
• Managing validation activities in FDA-regulated environments
• Training users on validation policies and requirements
• Reporting on validation metrics to Quality Management Review
• Mentoring and coaching validation staff
• Collaborating with clients, CMOs, and vendors
• Supporting and overseeing domestic ImmunityBio sites validation activities
• Implementing qualification practices aligned with industry standards

Responsibilities

Key responsibilities include:

• Developing and executing validation protocols
• Creating summary reports
• Managing validation activities
• Overseeing and supporting commissioning, cleaning validation, process validation, and equipment qualifications
• Interacting and collaborating with cross-functional departments
• Establishing project timelines and expectations
• Ensuring compliance with validate parameters
• Generating and approving SOPs, protocols, reports, and validation master plans
• Leading investigations related to validation discrepancies
• Managing staff by setting objectives, creating development plans, and completing performance reviews
• Collaborating and supporting the CSV team to validate computer systems
• Supporting and overseeing domestic ImmunityBio sites validation activities
• Implementing qualification practices to align with industry standards

Requirements

Requirements include:

• Bachelor’s degree in science or related discipline
• 10+ years of relevant validation or GMP-regulated industry experience
• Experience with facility commissioning and validation of equipment and facilities
• 5+ years of management experience
• Strong knowledge of process validation principles
• Strong experience in project management concepts
• Knowledge of Total Quality Management (TQM) philosophy
• Critical thinking and demonstrated problem-solving/root cause investigation skills
• Excellent technical document writing and reviewing with team
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11, and cleanrooms
• Experience with ELLAB data loggers and systems

Qualifications

Qualifications include:

• Excellent organization and communication skills, both written and verbal
• Strong knowledge of Six Sigma Lean ideology
• Experience with and knowledge of related quality systems such as change control, work order management systems, and document control
• Experience with and knowledge of related quality systems such as change control, work order management systems, and document control

Skills

Skills include:

• Demonstrated ability to 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; is attentive and approachable
• Strong knowledge of process validation principles
• Strong experience in project management concepts
• Knowledge of Total Quality Management (TQM) philosophy
• Critical thinking and demonstrated problem-solving/root cause investigation skills
• Excellent technical document writing and reviewing with team
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms
• Experience with and knowledge of related quality systems such as change control, work order management systems, and document control
• Experience with and knowledge of related quality systems such as change control, work order management systems, and document control

Benefits

ImmunityBio offers a comprehensive benefits package including:

• Medical, Dental, and Vision Plans
• 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) including 11 holidays

Pay

The annual base pay range for this position is $144,000 (entry-level qualifications) to $160,000 (highly experienced) annually.

Schedule

This position is on-site. Exposure to an onsite in-lab environment is required. Must be able to don and wear Personal Protective Equipment (PPE) as required. Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.