Manager, Quality Assurance
About The Position
The Manager, Quality Assurance is responsible for supporting and maintaining compliance with the Quality Management System (QMS) and applicable regulatory requirements. This role ensures that manufacturing, testing, and release activities for cell therapy products are conducted in accordance with cGMP standards and company procedures. The position provides day-to-day oversight of Quality Assurance activities, supports cross-functional teams, and contributes to risk assessment and continuous improvement initiatives. This role supports operations across the Santa Monica, CA and Tarzana, CA sites and reports to the Director of Quality Site Head. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world. At AstraZeneca, we follow the science and pioneer new frontiers. Our team is dedicated to Oncology with a vision to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, and collaboration, empowering you to lead at every level and take smart risks that drive patient outcomes. Ready to make a difference? Apply now and join us on this exciting journey!
Requirements
- Bachelor’s degree in Biological Sciences or related field with a minimum of 5+ years of Industry experience, or Master’s degree with 3+ years of experience, or PhD with 1 year of experience in a GMP-regulated environment.
- Strong knowledge of cGMP regulations and global regulatory requirements (US, EU, ROW).
- Experience with quality systems, including deviations, CAPAs, investigations, and change control.
- Experience supporting batch release and product disposition activities.
- Familiarity with internal and external audit processes and regulatory inspections.
- Strong organizational, problem-solving, and prioritization skills.
- Ability to work cross-functionally and build effective working relationships.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Ability to adapt to a fast-paced environment and apply phase-appropriate quality practices.
Nice To Haves
- Experience working with Quality Control and/or Facilities & Engineering is preferred.
Responsibilities
- Support management of the Quality Assurance team, including training, scheduling, and performance support of QA staff.
- Provide QA support to cross-functional groups including Manufacturing, Quality Control, Supply Chain, Process Development, and Regulatory Affairs.
- Ensure compliance with internal quality systems, regulatory requirements, and cGMP standards.
- Review batch records and associated documentation to support timely product disposition and release.
- Review and approve deviations, investigations, CAPAs, and change controls to support product quality and compliance.
- Participate in root cause investigations and support implementation of corrective and preventive actions.
- Support new product introductions (NPI), technology transfer, and process development activities from a QA perspective.
- Perform quality risk assessments and support continuous improvement initiatives.
- Monitor and trend quality metrics, and support Management Review activities.
- Assist with regulatory inspections and support internal and external audits.
- Review manufacturing and quality control data for in-process and finished products.
- Support development and revision of Standard Operating Procedures (SOPs) and other quality documents.
- Collaborate with stakeholders to resolve quality issues and ensure compliance across operations.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
