External Quality Director

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 will be responsible for:

• Provides quality oversight of the External Quality process for all of Development Quality Biologics.
• Manage and development of the DevQBio group including day to day needs, staff performance and strategy setting.
• Perform supplier qualification and monitoring and associated activities (risk assessments, investigations, complaint handling, etc.) to maintain license to operate and availability of suppliers for products in the clinical portfolio
• Operate as the AZ Quality point of contact for Contract Manufacturers (CMOs) and Contract Testing Labs (CTLs) for biologic portfolio projects
• Author and negotiate Quality-based agreements or sections of agreements (ESRs, Service Level Agreements, Quality Agreement) for CMOs, Clinical trials or Inter-company/Partner relationships with no oversight
• Working knowledge of CFRs, EMA, NMPA, JP, ICH and other guidance's, regulations and annexes
• Provide review of master and executed batch records and support disposition of material
• Manage and assess Supplier Initiated Changes
• Assist in Product Complaint an Non-Conformance investigations
• Enforcement of contractual obligations
• Provide on-site support/oversight at CMOs
• Participate in due diligence, audits and/or inspections
• Written and oral communication across multiple levels within AZ and at external suppliers
• Operate independently with minimum oversight

Education/Qualifications

• Bachelor's Degree in Biology, Biochemistry, Chemistry, Engineering or related fields
• 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 biologics experience
• 2+ years External/Supplier Quality management
• Working knowledge of local and international Biologicals GxP regulatory frameworks, regulations and guidance's
• Ability to work in a complex dynamic global environment
• Travel as required for site visits

Computer Skills: MS Outlook, MS PowerPoint, MS Excel, MS Word, Teams
Desirable:

• Drug Substance and/or Drug Product experience
• Graduate degree in related field
• Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company's values
• Experience with regulatory inspections

Working knowledge of international Biologicals 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
02-Jan-2024
Closing Date
Our 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.