Senior Auditor, Cell Therapy Quality

AstraZeneca

Senior Auditor overseeing complex audits of Cell Therapy manufacturing sites for AstraZeneca. Ensuring compliance with cGMP and other regulatory standards.

Posted 7/5/2026full-timeGaithersburg • California, Maryland • 🇺🇸 United StatesSenior💰 $127,995 - $191,995 per yearWebsite

About the role

Key responsibilities & impact

Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings
Performs complex and demanding domestic and international (subject to experience) audits of suppliers of raw materials, packaging components, drug substance or other process intermediates, and finished drug products, or contracted services
Audits are conducted in accordance with cGMP´s, ISO Standards, IPEC, ICH Q7A and company procedures
Plans, coordinates and conducts scheduled or unscheduled cGMP audits of complex internal AstraZeneca Operational departments to ensure compliance to CGMP´s and AstraZeneca standards
Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions
Liaise directly with local AZ and/or regional and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable
Interpret and apply cGMP regulations and expectations
Develop and interpret audits findings across the scope of the Global Quality Audit (GQA) in order to communicate trends and provide recommendations to address such developing trends in a proactive manner

Requirements

What you’ll need

10 years experience in a QA environment with increasingly responsible job requirements including audit experience
Extensive knowledge of Cell Therapy Products and Cell Therapy Specific Regulations
Bachelors degree in a scientific discipline
AZ business language in English
Self-directed and highly motivated team player with solid organizational capabilities
Cross-cultural awareness and sensitivity
Excellent written and verbal communication skills
Ability to manage stressful and confrontational situations to positive outcomes
Ability to travel extensively (up to 60% of time local/regionally/global)
Proven ability to continually refresh cGMP interpretation and application through self-study and external involvement with industry groups
Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance arena.

Benefits

Comp & perks

Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program
Retirement contribution (hourly roles)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality AuditingCGMP ComplianceRisk AssessmentCorrective And Preventive Action DevelopmentAudit Findings InterpretationISO Standards KnowledgeIPEC Standards KnowledgeICH Q7A KnowledgeModern Quality SystemsCell Therapy Specific Regulations

Soft Skills

Self-DirectedHighly Motivated Team PlayerSolid Organizational CapabilitiesCross-Cultural AwarenessAbility To Manage Stressful Situations