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. This role is accountable for the leadership and management of the Quality Assurance team as well as supporting routine Quality Assurance (QA) duties related to the production and disposition of cell therapy products manufactured and tested on behalf of AstraZeneca. This role supports the Santa Monica, CA and Tarzana, CA sites and reports to the Director of Quality.

Responsibilities

• Provide leadership and management to the overall Quality Assurance team, including, but not limited to, staff hiring, staff scheduling, staff training, and staff coaching/mentoring/performance management.
• Provide quality assurance support across departments (Manufacturing, Supply Chain, QC, Process Development, Regulatory Affairs) within AstraZeneca and externally to assure compliance and relationships.
• Perform several activities to ensure compliance with applicable quality goals and regulatory requirements.
• Batch documentation ensure resolution of issues to release product.
• Approval of deviations and corrective and preventive actions (CAPAs) which support disposition of product for U.S. and other countries.
• Support New Product Introductions.
• Support quality assessments of internal operations to analyze quality compliance and assess risk.
• Provide QA guidance on product development projects and technical transfer activities
• Support Management Review activities and oversee trending of important quality, product and GMP metrics.
• Support regulatory inspections, internal audits, and external audits from partners.
• Develop QA Standard Operating Procedures to ensure Quality goals are met
• Review routine manufacturing and quality control data for in-process and finished product.
• Develop solutions to more complex problems.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

Education and Experience

• Bachelor's degree with a minimum seven (7) years of experience or Master's Degree and a minimum five (5) years of experience or PhD with a minimum of two (2) years of experience in a GMP environment.
• Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Experience conducting internal and external audits.
• Experience supporting Quality Control Analytical and Facilities & Engineering teams.
• Will to accept temporary responsibilities outside of initial job description.
• Ability build collaboration amongst individuals.
• Proficient in MS Word, Excel, Power Point and other applications.
• Willingness to think outside of the box and adapt best practices for stage appropriate products.
• Demonstrate organizational, prioritization, and proficiency.

#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.