Manager, Quality Assurance

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.

Key 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.

Education & Experience

• Bachelors degree in Biological Sciences or related field with a minimum of 5 years of Industry experience or Masters 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.

• Experience working with Quality Control and/or Facilities & Engineering is preferred.

• 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.

#LI-onsite #CellTherapy

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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!

The annual base pay for this position ranges from $100880.80 - $151321.20. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. 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 pay (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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.