The Manager, Quality Assurance supports and maintains compliance with the Quality Management System and applicable regulatory requirements to ensure product quality and safety
Job Summary
The Manager, Quality Assurance supports and maintains compliance with the Quality Management System and applicable regulatory requirements to ensure product quality and safety.
The role offers a competitive salary range with bonus and equity opportunities, along with comprehensive benefits including retirement plans, paid leave, and health coverage.
AstraZeneca fosters an inclusive environment focused on oncology innovation, encouraging collaboration, courage, and curiosity to pioneer new frontiers in medicine.
Matching Summary
The Manager, Quality Assurance supports and maintains compliance with the Quality Management System and applicable regulatory requirements to ensure product quality and safety.
Salary
Base: $129,556.80 - $194,335.20; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program; Benefits: 401(k), paid vacation and holidays, paid leaves, medical, prescription drug, dental, and vision coverage
Skills & Requirements
Must-have
Quality Management System compliance
cGMP standards adherence
Batch record review and approval
Deviation and CAPA management
Cross-functional team collaboration
Regulatory inspection support
Nice-to-have
Strong organizational skills
Problem-solving and prioritization
Microsoft Office proficiency
Ability to work in fast-paced environment
Experience with Quality Control and Facilities
Key Requirements
Bachelor’s degree in Biological Sciences or related field
Minimum 5 years industry experience in GMP environment
Master’s degree with 3+ years experience or PhD with 1 year experience
Strong knowledge of cGMP and global regulatory requirements
Experience with deviations, CAPAs, investigations, and change control
Experience supporting batch release and product disposition