Senior Director, GTO Validation and Packaging Transfer

Location: Gaithersburg or Frederick

Join us in a pivotal leadership role within the Global Technical Operations team at AstraZeneca.

As the Senior Director, Validation and Packaging Transfer, you will a member of the Tech Transfer & Validation Leadership Team at the forefront of strategic planning and coordination of technical leadership. You will work closely with the Biologics Global Technical Operations and CMC teams to establish deliverables of new drugs, therapies and vaccines to patients through global supply chains. This is your chance to make a meaningful impact on people's lives with life-changing medicines.

Your core responsibilities will include:

• Lead and manage a team of 6-8 experienced subject-matter experts responsible for execution of Assembly/Label/Pack tech transfer projects and DS and DP shipping qualification to establish global supply chains.
• Coordinate and oversee validation program continuous improvement initiatives and lean validation methodology, leading Operations engagement with various technical, quality, and leadership teams.
• Work with stakeholders to build and deliver on a vision for sustainable package engineering and shipping qualification practices.
• Leadership and oversight with multi-disciplinary teams across the enterprise to implement validation best practices, guidelines and training packages.
• Champion and initiate modernization through authoring and updating procedures and guidelines with consideration of current good practices across the Global Network and industry benchmarking coupled with state-of-the-art approaches with a focus toward lean and risk-based approaches.
• Oversee portfolio of Tech transfer & Validation strategic projects such as Global Standardization initiatives.
• Establish Business Process Management focus and priorities to drive operational excellence of the Tech Transfer & Validation organization and its ecosystem. This will include a “blueprint” of standard work and “playbook” defining aligned ways of working.
• Champion the positive evolution of tech transfer and validation through continuous improvement by translating opportunities into practical and implementable program plans.
  
  
  

Essential skills and experience:

• Bachelor’s degree in Engineering/Sciences or equivalent, with ten plus years of experience.
• Expertise in at least three of the following areas: Engineering of packaging and shipping solutions for biologics drug products, Validation concepts, regulations and industry best practices - especially PPQ strategies for tech transfer, ASTME risk-based approach to CQV, and Business process excellence.
• Deep experience in a logistics and/or manufacturing environment, preferably in biopharma or related regulated industry; (PPQ, CPV, cleaning validation, drug substance, drug products, equipment CQV, quality by design, etc.).
• Strong understanding and experience in qualification and validation life-cycle activities and validation compliance.
• Expert in GDP requirements and regulatory bodies interpretation of these requirements
• Advanced commercial acumen and ability to influence and direct stakeholder decision-making at senior levels
• Proven track record to inspire change globally within a diverse and matrix organizational environment
• Ability to work independently, collaborate with others, and lead interdisciplinary meetings.
  
  
  

Desired skills and experience:

• Master’s Degree preferred.
• Experience with new modalities (ADCs, radio conjugates, cell therapies, etc.)
• Experience with digital transformation within this space (paperless validation, etc.)
• Project/Portfolio Management and/or Lean/Six Sigma experience or certification.
• Strong understanding and experience in temperature-controlled transport, packaging and monitoring solutions qualification, process validation and temperature-controlled logistics industry standards
• Experience in supplying solutions and services either as a specialist solutions provider or as a Logistics Services Provider for pharmaceutical products.
  
  
  

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 driven by innovation, collaboration, and the desire to make a difference in people's lives. With constant new products and launches, there's never been a better time to join our Supply Chain team. We are united behind a common goal to succeed, we take our collective learnings and work as a team to keep pushing the boundaries of Supply Chain. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you want to make a big impact, this is the place for you. Our contribution to life-changing medicines is why people have been here for decades. We do it for the patients.

Ready to make your mark? Apply today!