Senior Director, Site Quality Head of Cell Therapy Operations
Introduction to Role:
Are you ready to make a bigger impact on patients? As the Senior Director, Site Quality Head of Cell Therapy Operations, you will report into the Vice President, Global Biologics Quality. Your role will be to lead and direct the site Quality Operations, develop strategic plans and deliver operational results. You will define innovative solutions within the most complex and ambiguous areas of the business, lead other managers and provide strategic direction for the organization through a comprehensive understanding of site and impact across global operations.
In this role, you will be responsible for creating and staffing the new Quality organizational structure for the Commercial Cell Therapy Facility to support facility start-up and routine production. You will ensure the continued suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance. You will establish appropriate Quality processes and oversight models based on current and evolving regulation to ensure patient safety and License to Operate. You will also contribute to the multidisciplinary team responsible for manufacturing novel Cell Therapy products for pivotal clinical studies and commercial supply. Are you ready to take on these challenges?
- 15+ years applicable experience with B.S. degree in Science, Engineering, Biochemistry Pharmacy or related technical field is required.
- 12+ years applicable with M.S. degree in Science, Engineering, Biochemistry, Pharmacy or related technical field is preferred.
- 5+ years direct autologous Cell Therapy experience.
- 5+ years management experience.
- 3+ years Cell Therapy Quality experience including clinical lot release.
- Experience with product launches, health authority inspections and global commercial product distribution requirement
- Proven ability to work in a fast-paced environment across multiple technical functions.
- Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply.
- Proven track record of attracting and developing talent.
- Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance
- PhD in Science, Engineering, Biochemistry, Pharmacy or related technical field
- Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company’s values
- Experience with Cell Therapy IND and MA submissions
- Experience with Cell Therapy regulatory inspections
- Experience engaging with global regulatory bodies
- Allogenic Cell Therapy experience
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 ambitious world.
At AstraZeneca, we are united behind one mission: finding the best solution to put our patients first. With constant new products and launches, there's never been a better time to join our Supply Chain team and shape our future with a big contribution to life-changing medicines. We are a diverse, multigenerational team of experts connected across the globe. We interpret the science, connecting it with the business need to apply manufacturing excellence. If you are driven, take smart risks and are able to act quickly, then this is the place for you.
Ready to make a bigger impact on patients? Apply now!
Closing Date14-Feb-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.