Associate Director, Validation

. Direct Grifols Biologicals LLC Validation program in accordance with current GMP and quality standards .

Posted 10/15/2026full-timeLos Angeles • California • United StatesSenior💰 $160,000 - $190,000 per yearWebsite

Key responsibilities & impact

Direct Grifols Biologicals LLC Validation program in accordance with current GMP and quality standards
Develop validation strategy and policy to streamline and simplify the validation approach
Review and approve validation protocols and reports
Generate and enforce validation project priorities, emphasizing critical projects
Coordinate validation documentation and justifications for regulatory submissions
Develop and implement employee training to increase validation knowledge and policy adherence
Maintain Validation Master Plans and schedules for manufacturing and packaging areas
Develop and implement responses to audit observations concerning validation
Collaborate with Research and Development, Quality Control, Engineering, and Manufacturing on validation planning
Supervise Validation personnel, including hiring, development, motivation, and work direction
Determine validation requirements for equipment, facilities, utilities, commodities, and processes under change control or new projects
Direct completion of validation documentation before manufacturing plant changes are implemented
Oversee the Filtered Air System department, including procedures, filter maintenance, and work direction

What you’ll need

Bachelor's degree in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related scientific/technical discipline required
An equivalent combination of education and experience may be taken into consideration
6 years of Validation experience in a pharmaceutical, GMP, or FDA regulated medical device industry
Minimum of 4 years of managerial, supervisory, or leadership experience required
In-depth understanding of validation principles and qualification requirements, particularly sterilization systems and aseptic processing
Comprehensive knowledge of cGMPs, FDA regulations, and industry guidelines
Demonstrated leadership, project management, organizational, analytical, and problem-solving skills
Strong interpersonal, verbal, and written communication skills in the English language
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
Flexibility with working hours/shifts to accommodate 24-hour, 7-day plant operation
Ability to frequently drive to site locations and travel within the United States

Comp & perks