Associate Director, Validation

GRIFOLS, S.A.•CA-Los Angeles, CA

1d•$160,000 - $190,000•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. The role ensures the qualification of equipment, utilities, processes, facilities, and supporting manufacturing systems. It develops validation strategy and policy, sets project priorities, and oversees validation documentation, planning, and compliance. The position also supervises Validation personnel and oversees the Filtered Air System (FAS) department. The role collaborates with Research and Development, Quality Control, Engineering, and Manufacturing on validation planning, standards, and requirements. It is based at the Valley Boulevard manufacturing plant in Los Angeles, California, and involves frequent travel to site locations and within the United States. The work is performed in an office environment, with flexibility in working hours or shifts to accommodate a 24-hour, seven-day plant operation.

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, FDA-regulated, or medical device industry 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.
Ability to inspire high performance and align team members around shared goals.
Leadership skills to motivate, guide, train, coach, and develop department personnel.
Project management skills.
Strong organizational, analytical, and problem-solving skills, including the ability to make structured routine decisions.
Proactive, results-oriented approach and strong attention to detail.
Self-starter with a strong work ethic and sound judgment.
Ability to prioritize and manage multiple tasks to meet 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 with MS Office, including Outlook, Word, Excel, and PowerPoint.
Flexibility with working hours or shifts to accommodate 24-hour, seven-day plant operations.

Nice To Haves

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

Responsibilities

Direct the Grifols Biologicals LLC Validation program in accordance with current GMP and quality standards.
Develop validation strategies and policies to streamline and simplify validation approaches.
Review and approve validation protocols and reports to ensure regulatory and quality requirements are met and maintained.
Establish and enforce validation project priorities, emphasizing the most critical projects.
Coordinate validation documentation and justifications for regulatory agency submissions.
Develop and implement methods, including employee training, to increase validation knowledge and adherence to validation policies.
Maintain Validation Master Plans and schedules for each manufacturing and packaging area.
Develop and implement responses to audit observations related to validation.
Collaborate with Research and Development, Quality Control, Engineering, and Manufacturing on validation planning, and communicate validation standards and requirements.
Directly supervise Validation personnel, including hiring, developing, motivating, and directing their work toward business goals and objectives.
Determine validation requirements for equipment, facilities, utilities, commodities, and processes under Change Control or new projects.
Direct completion of validation documentation before planned manufacturing plant changes are implemented.
Oversee the Filtered Air System department, including reviewing and approving procedures, ensuring scheduled filter maintenance, and directing work toward business goals.