Associate Director – Validation

AstraZeneca • Los Angeles, CA

2d • $138,771 - $208,156 • Onsite

About The Position

The Associate Director – Validation leads and manages the validation program within the Facilities and Engineering department, supporting site-wide validation needs. This includes Site and Project Validation Master Plans; facility and equipment commissioning, qualification, and validation (CQV); equipment lifecycle validated-status assessments; validation documentation packages; and compliance with cGMP regulations. The role provides expert technical guidance, oversees complex projects, and ensures systems and processes meet regulatory requirements and support operational efficiency.

The role establishes the site validation strategy and program in alignment with cGMP requirements and global company procedures, and works with operations, quality assurance, and quality engineering to coordinate validation strategy across the site and global organization. It leads technical teams and CQV deliverables, manages validation project planning and execution, oversees documentation and compliance activities, supports audits, and identifies opportunities to improve the validation program. The position is based in Tarzana, California, with office and on-site facilities work and occasional travel to company sites or off-site locations.

Requirements

• Bachelor’s degree in Engineering or a related life sciences field.
• 10–12 years of experience in validation program management, engineering, and capital projects, with significant experience in a pharmaceutical or regulated industry.
• Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.
• Proven experience leading complex validation processes, asset life-cycle validated-status management, capital engineering projects, and technical teams.
• Strong project management skills, including budgeting, scheduling, and resource allocation.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple priorities and work effectively under pressure.

Nice To Haves

• Master’s degree.

Responsibilities

• Establish a site validation strategy and comprehensive validation program aligned with cGMP industry requirements and global company procedures.
• Collaborate with operations, quality assurance, and quality engineering to align and drive validation strategy across the site and global organization through project-based and routine assessment activities.
• Set long-term technical validation direction for systems and processes supporting the clinical-to-commercial validation life cycle.
• Lead validation-focused technical teams and guide execution of facilities and equipment CQV deliverables.
• Lead development and execution of validation strategies, specification documents, test protocols, and documentation for systems, facilities, equipment, and processes.
• Ensure qualification and validation activities meet regulatory requirements, including FDA and EMA requirements, and internal global standards.
• Manage complex validation projects, including asset specification and procurement, facility fit planning, and design, execution, and reporting of internal and external qualification protocols.
• Oversee validation review-gate assessments within change-control and asset-induction processes in the asset life-cycle program.
• Prepare and review validation documentation in the Enterprise Quality Vault (EQV) and align it with applicable global procedures and standards.
• Establish validation document review cycles and drive processes for document review and revision.
• Ensure validation documentation is accurate, complete, and compliant with regulatory requirements.
• Ensure facilities, systems, and processes comply with regulatory and industry qualification and validation standards.
• Develop and enforce validation gap-assessment and remediation plans.
• Conduct internal validation assessment audits and inspections, and address identified issues promptly.
• Support internal and external audits as a subject matter expert by formulating technical responses and presenting directly to auditors.
• Identify and implement validation process improvements to enhance efficiency, reduce costs, and strengthen the validation program, including possible use of matrix approaches such as family groups.
• Stay current with industry trends, technological advancements, and regulatory changes to apply best practices.
• Occasionally travel to company sites or off-site locations and, when needed for urgent issues or project needs, work evenings or weekends.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior