Associate Director, Quality Assurance

Position Summary

The Associate Director Quality Assurance position ensures compliance with the quality system's procedures and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. You will manage the Quality Assurance team and supporting routine Quality Assurance (QA) responsibilities related to the production and disposition of cell therapy products manufactured and tested on behalf of AstraZeneca. You will support the Santa Monica, CA and Tarzana, CA sites and reports to the Director of Quality.

Responsibilities

• Provide leadership to the Quality Assurance (QA) team, including hiring, scheduling, training, and performance management of staff.

• Support cross-departmental functions such as Manufacturing, Supply Chain, QC, Process Development, and Regulatory Affairs to ensure compliance and maintain relationships.

• Perform activities to ensure adherence to quality goals and regulatory requirements.

• Resolve batch documentation issues to facilitate product release.

• Approve deviations and corrective and preventive actions (CAPAs) to support product disposition for U.S. and global markets.

• Provide QA support for New Product Introductions.

• Conduct quality assessments of internal operations to evaluate compliance and manage risk.

• Offer QA guidance on product development projects and technical transfer activities.

• Support Management Review processes and oversee trending of important quality, product, and GMP metrics.

• Participate in regulatory inspections, internal audits, and audits conducted by external partners.

• Develop and implement QA Standard Operating Procedures (SOPs) to meet quality goals.

• Review routine manufacturing and quality control data for both in-process and finished products.

• Develop solutions to address complex quality issues.

• Lead investigations and recommend CAPAs related to manufactured products.

Education and Experience

#LI-onsite #CellTherapy

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!

The annual base pay (or hourly rate of compensation) for this position ranges from $122,820 - $184,231Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.