Executive Director, Quality

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

We are looking for an accomplished and experienced individual to join our team as the Head of Quality for our Cell Therapy unit. You will oversee and ensure the highest standards of quality and compliance within our cell therapy operations. This role is important to maintaining regulatory compliance, improving, and promoting a culture of quality excellence.

Responsibilities

• Accountable for all aspects of GMP Quality for AstraZeneca’s cell therapy programs and phase appropriate compliance of cell therapy manufacturing sites.
• Provide strategic management to the Cell Therapy Quality organization. Accountable for the establishment and Quality oversight of the global processes specific to Cell Therapy clinical and commercial programs
• Ensure the Quality processes used are fit for purpose, GxP compliant and support Clinical development timelines and future commercial launch considering the unique aspects of Cell Therapy production.
• Design, hire and lead an empowered team of Quality experts providing quality oversight for different business processes supporting Cell Therapy production.
• Provide Quality oversight and support for End to End Patient Operations  processes.
• Provide Quality oversight of contract manufacturers, outside testing labs; ensure a supplier management system.
• Develop an environment of collaborations and partnership with internal functions and team members and with external partners.
• Establish and maintain a Cell Therapy Quality Management System (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards (e.g., GMP, GCP).
• Lead Cell Therapy Quality Assurance (QA) and Quality Control (QC) teams, providing guidance in all quality-related matters.
• Conduct internal audits and oversee external audits and inspections to ensure readiness and compliance.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Clinical Development teams to guide quality programs throughout the product lifecycle.
• Improve programs through data analysis, trend identification, and implementation of corrective and preventive actions (CAPAs).
• Provide leadership and mentorship to the quality team, promoting a culture of quality, accountability, and compliance awareness.
• Be a primary contact for quality-related communications with regulatory authorities and external partners.

Education and Experience

• Advanced degree in life sciences, pharmaceutical sciences, or a related field.
• 15+ years of experience in quality assurance and quality control within the biopharmaceutical or cell therapy industry.
• Lead in quality management in a cell therapy or biologics environment.
• Knowledge of GxP regulations and how to apply them to clinical and commercial products to guarantee patient safety and ensure the appropriate level of compliance.
• Agile leader who expresses commitment to align others embracing change.
• Knowledge of global regulatory requirements and guidelines about cell therapy products.
• Experience with QMS implementation and management, including CAPA systems, change control, and document management.

When we put unexpected teams in the same room, we fuel 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 ambitious world.

The annual base salary for this position ranges from $230,000 to $271,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement

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 authorization and employment eligibility verification requirements.