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Senior Director, Quality Site Head – Cell Therapy
AstraZeneca. Lead a large Site Quality support function across the Tarzana and Santa Monica manufacturing sites .
Posted 10/5/2026full-timeSanta Monica • California • United StatesSenior💰 $207,000 - $300,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Cell Therapy Quality Management, including compliance with GxP regulations and oversight of product release processes. Proven leadership in developing quality strategies and managing multidisciplinary teams to ensure patient safety and operational excellence.
Highest-signal resume keywords
Cell Therapy Quality ExperienceGood Manufacturing Practices ComplianceLeadership ExperienceRegulatory Body EngagementChange Management Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Cell Therapy ExperienceQuality AssuranceQuality ControlQuality SystemsClinical Lot ReleaseProduct LaunchesHealth Authority InspectionsGxP Regulatory FrameworksBudget ManagementTalent Development
Soft Skills
Decision Making Under PressureInfluencing Senior StakeholdersCollaborationContinuous Improvement MindsetTalent Attraction
Industry Keywords
Cell TherapyClinical SupplyCommercial SupplyCompliance AuditingSite Quality StrategyPatient SafetyGlobal Quality NetworkAllogenic Cell TherapyAutologous Cell TherapyIND and MA Submissions
About the role
Key responsibilities & impact- Lead a large Site Quality support function across the Tarzana and Santa Monica manufacturing sites
- Create and staff the Quality organizational structure for current clinical supply and future commercial supply
- Contribute to multidisciplinary teams manufacturing novel Cell Therapy products
- Lead delivery of Quality Assurance, Quality Control, and Quality Systems & Compliance to site manufacturing plans
- Develop innovative Quality strategies to enable life-saving medicines to reach patients
- Assess CTTO strategies and develop and implement CTQ recommendations
- Monitor the evolving Cell Therapy Quality landscape
- Partner with senior CTTO and CTQ leaders to identify and remove delivery blockers
- Own the Site Quality strategy and Quality Management System business process
- Lead Site Quality initiatives and improvement programs for compliance, continuous improvement, quality commitment, and COGM improvement
- Oversee product release and compliance auditing processes
- Support relationships with regulatory bodies and resolve site issues
- Support the AstraZeneca Global Quality network relationship
- Manage Business Unit performance, effectiveness, resources, talent development, performance and attendance management
- Ensure Good Manufacturing Practices and Safety, Health, and Environment compliance
- Manage expenditure against budget
- Drive development of the Site Leadership Team through common objectives and behavioral standards
- Collaborate with the Site Leadership Team to align site strategy with CTTO and customer/patient needs
Requirements
What you’ll need- 15+ years applicable experience with a B.S. degree in Science, Engineering, Biochemistry, Pharmacy or related technical field
- 12+ years applicable experience with an M.S. degree in Science, Engineering, Biochemistry, Pharmacy or related technical field
- 5+ years direct autologous Cell Therapy experience
- 5+ years management experience
- 3+ years Cell Therapy Quality experience including clinical lot release
- Experience with product launches, health authority inspections and global commercial product distribution requirements
- Proven ability to work in a fast-paced environment across multiple technical functions
- Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply
- Proven track record of attracting and developing talent
- Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance
- Ability to influence senior stakeholders, both internally and externally
- Preferred: PhD in Science, Engineering, Biochemistry, Pharmacy or related technical field
- Preferred: Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company’s values
- Preferred: Experience with Cell Therapy IND and MA submissions
- Preferred: Experience with Cell Therapy regulatory inspections
- Preferred: Experience engaging with global regulatory bodies
- Preferred: Allogenic Cell Therapy experience
Benefits
Comp & perks- In-person working with individual flexibility
- Inclusive environment with equal employment opportunities
- Disability or special-needs accommodation support