Senior Validation Director CQV & GMP Compliance

AstraZeneca plc; Los Angeles (CA); On-site; USD 139,000 - 208,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation and holidays

Equity-based long-term incentive

Job summary

AstraZeneca plc in Tarzana, California seeks an Associate Director – Validation to lead the site-wide validation program across facilities and equipment. You will guide CQV activities, ensure regulatory compliance with GMP/FDA standards, and coordinate cross-functional teams to sustain validation lifecycle integrity.

The role demands expert technical leadership, project oversight, and the ability to drive continuous improvement while managing complex, multi-site validation initiatives within a

Qualifications

• Bachelor’s degree in Engineering or related life sciences field; Master’s preferred.
• 10–12 years leading validation programs, engineering and capital projects.
• Extensive GMP, FDA regulations knowledge and compliance experience.
• Proven ability to lead complex validation processes and teams.
• Strong budgeting, scheduling, and resource management skills.
• Excellent analytical, problem-solving and communication abilities.

Responsibilities

• Lead and manage site-wide validation strategy and program.
• Collaborate with operations, QA, and QA Engineering to drive validation
• Oversee CQV for facilities, equipment, and processes and ensure regulatory compliance.
• Manage complex validation projects including asset life cycle and qualification design.
• Prepare validation documentation in EQV and drive review cycles.
• Support internal and external audits as subject matter expert.

Skills

Validation leadership

Regulatory compliance

Project management

GMP knowledge

Cross-functional collaboration

Budgeting & scheduling

Education

Bachelor's degree in Engineering or life sciences

Master's degree preferred

Tools

EQV (Enterprise Quality Vault)

Change control systems

Job description

AstraZeneca plc in Tarzana, California seeks an Associate Director – Validation to lead the site-wide validation program across facilities and equipment. You will guide CQV activities, ensure regulatory compliance with GMP/FDA standards, and coordinate cross-functional teams to sustain validation lifecycle integrity.

The role demands expert technical leadership, project oversight, and the ability to drive continuous improvement while managing complex, multi-site validation initiatives within a