Quality Director- Cell Therapy

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 guides in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals.

• What you’ll do: Lead a Quality function or high-level project and develops strategic and operational plans to ensure successful delivery. Defines innovative solutions within the most complex and ambiguous areas of the business. Leads other managers and provides strategic direction for the organization through a comprehensive understanding of global issues.

Responsibilities:

• Assists in establishment of phase-appropriate Cell Therapy Quality requirements based on current and evolving regulation to ensure patient safety and License to Operate
• Contributes to the multidisciplinary team responsible to develop and manufacture novel Cell Therapy products
• Develop and maintain the Quality System to enable manufacture of the Cell Therapy portfolio
• Participates in investigations, assessments, and evaluations of quality records such as deviations, CAPAs, and change controls
• Manages, develops and leads a team of Quality Assurance professionals
• Supports the planning process to drive continuous improvements and changes of the Quality System to ensure on-going effectiveness, efficiency and sustainability
• Partners with Quality and Development leadership to identify and remove blockers to ensure delivery of an integrated approach to Cell Therapy Quality across the business
• validation protocols/reports.
• Provide hands-on QA support and oversight to internal staff to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements
• Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies

Education/Qualifications

• 8+ years applicable experience with B.S. degree in Science, Engineering, Pharmacy or related technical field
• 5+ years applicable with M.S. degree in Science, Engineering, Pharmacy or related technical field
• 2+ years management experience
• 2+ years Cell Therapy Quality Assurance experience including clinical lot release

Desirable:

• PhD in Science, Engineering, 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 CT regulatory inspections
• Working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being bold - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking innovative methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be an outstanding fit, please share this posting with them.

Date Posted

Closing Date

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.