Associate Director, Validation

Grifols•Los Angeles, CA

3d•Onsite

About The Position

The Associate Director of Validation supports and directs Grifols Biologicals LLC’s Validation program in accordance with current GMP and quality standards, ensuring the qualification of equipment, utilities, processes, facilities, and supporting manufacturing systems. The position develops validation strategy and policy, oversees validation planning and documentation, and ensures that regulatory and quality requirements are met and maintained. The role directly supervises Validation personnel and oversees the Filtered Air System (FAS) department. It collaborates with Research and Development, Quality Control, Engineering, and Manufacturing teams, and requires flexibility in working hours to accommodate a 24-hour, 7-day plant operation. Work is performed in an office environment, with frequent driving to site locations and travel within the United States. The position is based at the Valley Boulevard Manufacturing Plant in Los Angeles, California.

Requirements

Bachelor’s degree in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or a related scientific or technical discipline; an equivalent combination of education and experience may be considered.
Six years of validation experience in a pharmaceutical, GMP, or FDA-regulated environment.
At least four years of managerial, supervisory, or leadership experience.
In-depth understanding of validation principles and qualification requirements for a range of systems, particularly sterilization systems and aseptic processing.
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Demonstrated ability to inspire high performance and align team members around shared goals.
Demonstrated ability to motivate, guide, train, coach, and develop department personnel.
Demonstrated project management skills.
Strong organizational, analytical, and problem-solving skills, with the ability to make structured decisions routinely.
Proactive, results-oriented approach and strong attention to detail.
Strong work ethic, self-direction, and ability to exercise good judgment.
Ability to prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills and ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in English.
Computer literacy and proficiency in MS Office, including Outlook, Word, Excel, and PowerPoint.
Flexibility with working hours and shifts to accommodate a 24-hour, 7-day plant operation.
Ability to communicate complex information clearly and understand information presented through spoken words and sentences.
Ability to interact frequently with others and relate sensitive information to diverse groups.
Ability to apply abstract principles to complex conceptual issues and perform complex tasks under variable demands and changing conditions.

Nice To Haves

Master’s degree and/or Ph.D.
Leadership experience in a related industry.

Responsibilities

Direct the GB Validation program in accordance with current GMP and quality standards to ensure qualification of equipment, utilities, processes, facilities, and supporting manufacturing systems.
Develop validation strategy and policy to streamline and simplify the validation approach.
Review and approve validation protocols and reports to ensure regulatory and quality requirements are met and maintained.
Generate and enforce priorities for validation projects, emphasizing the most critical projects.
Coordinate validation documentation and justifications for submissions required by regulatory agencies.
Develop and implement methods, such as employee training, to increase validation knowledge and facilitate adherence to GB’s validation policies.
Maintain Validation Master Plans and schedules for each area of manufacturing and packaging.
Develop and implement responses to audit observations concerning validation.
Collaborate with Research and Development, Quality Control, Engineering, and Manufacturing departments on validation planning and communicate validation standards and requirements.
Directly supervise Validation personnel, including hiring, developing, motivating, and directing work to promote achievement of business goals and objectives.
Determine validation requirements for equipment, facilities, utilities, commodities, and processes under Change Control or in new projects.
Direct completion of validation documentation before planned changes to the manufacturing plant are implemented.
Oversee the Filtered Air System department, including reviewing and approving FAS procedures, ensuring scheduled filter maintenance, and directing work to achieve business goals and objectives.