Associate Director – Validation

AstraZeneca; Los Angeles (CA); In loco; USD 139.000 - 208.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) plan

Paid vacation and holidays

Equity-based long-term incentive

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Validation leadership

Regulatory compliance

Project management

GMP knowledge

Cross-functional collaboration

Budgeting & scheduling

Formazione

Bachelor's degree in Engineering or life sciences

Master's degree preferred

Strumenti

EQV (Enterprise Quality Vault)

Change control systems

Descrizione del lavoro

Associate Director – Validation

Tarzana, California

Job Summary

The Associate Director – Validation is responsible for leading and managing the validation program within the Facilities and Engineering department supporting validation needs site wide, including Site and Project Validation Master Plans, facility and equipment commissioning / qualification / validation (CQV) processes, equipment life cycle validated status assessments, validation documentation packages, and compliance with cGMP regulations within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency.

Key Responsibilities

• Validation Program Leadership and Oversight:
  • Establish a robust site validation strategy and deploy a comprehensive site validation program that aligns to cGMP industry requirements and global company procedures.
  • Collaborate with cross-functional teams, including operations, quality assurance, and quality engineering, to align and drive validation strategy across the site and the global organization via project based and routine assessment activities.
  • Owner/architect of long term technical validation direction with focus on systems and processes that support the clinical to commercial validation life cycle.
  • Lead validation focused technical teams and provide guidance through execution of facilities and equipment CQV deliverables.
• Commissioning / Qualification / Validation Management:
  • Lead teams through the development and execution of validation strategies, specification documents, test protocols, and documentation for systems, facilities, equipment, and processes.
  • Ensure that all qualification and validation activities meet regulatory requirements (e.g., FDA, EMA) and internal global standards.
  • Manage complex validation projects, including elements of asset specification, asset procurement, facility fit planning, and external / internal qualification protocol design, execution, and reporting.
  • Oversee the validation review gate assessment as part of the change control and asset induction processes within the asset life cycle program.
• Validation Documentation and Reporting:
  • Prepare and review comprehensive documentation for validation within the Enterprise Quality Vault (EQV) and align to global procedures / standards where appropriate.
  • Ensure that validation document review cycles are established and drive the implementation of a process for document review and revision.
  • Ensure that validation documentation is accurate, complete, and compliant with regulatory requirements.
• Validation Systems Compliance:
  • Ensure all facilities, systems, and processes comply with regulatory and industry standards with respect to qualification and validation requirements.
  • Develop and enforce validation gap assessment and remediation plans.
  • Conduct regular internal validation assessment audits and inspections to ensure compliance and address any issues promptly.
  • Support internal and external audits as a subject matter expert, formulating technical audit responses and presenting directly to auditors.
• Validation Program Continuous Improvement:
  • Identify and implement validation process improvements to enhance efficiency, reduce costs, and improve validation program robustness. This may include the implementation of matrix approach practices such as family groups.
  • Stay current with industry trends, technological advancements, and regulatory changes to ensure best practices are applied.

Qualifications

• Bachelor’s degree in Engineering, or a related life sciences field; Master’s degree preferred.
• 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 in leading complex validation processes, asset life cycle validated status management, capital engineering projects, and leading technical teams.
• Strong project management skills with experience in budgeting, scheduling, and resource allocation.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple priorities and work effectively under pressure.

Working Conditions

• Office and on-site facilities environment, with occasional travel to various company sites or off-site locations.
• May require occasional evening or weekend work to address urgent issues or project needs.

Benefits and Compensation

The annual base salary for this position ranges from $138,771 and $208,156 USD Annual. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Company Culture

AstraZeneca is where science meets innovation to create impactful solutions! We challenge the status quo by leveraging data to drive scientific breakthroughs that make a tangible difference in patients' lives.

Our collaborative environment fosters learning and growth, empowering you to contribute to meaningful research across global Therapy Areas. With countless opportunities for development, AstraZeneca is committed to investing in technology and expanding knowledge to maximize impact.

Additional Information

Date Posted: 27-Oct-2026

Closing Date: 09-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.