REMs Distribution and Supply Chain Operations

Are you ready to make a significant impact in the world of supply chain operations?

As part of our REMS Distribution and Supply Chain Operations team, you'll play a crucial role in ensuring compliance with REMS requirements, FDA guidelines, and GxP standards. This position is pivotal in developing, executing, and monitoring distribution procedures while collaborating with internal teams, external partners, and regulatory authorities. Your work will support REMS objectives, improve patient safety, and drive central initiatives for a successful REMS journey. Join us in shaping the future of supply chain operations!

Accountabilities

• Ensure all product distribution activities align with REMS requirements, FDA guidelines, and GxP.
• Monitor regulatory changes and update distribution processes accordingly.
• Maintain accurate records of distribution transactions and REMS documentation.
• Collaborate cross-functionally to support REMS documentation for inspections or audits.
• Support the successful implementation of new REMS.
• Develop and implement SOPs for REMS-compliant distribution.
• Seek opportunities for process improvement and suggest solutions.
• Manage strategies and tactics to support REMS compliance in distribution and supply chain.
• Update internal distribution systems to support REMS activities.
• Prepare for REMS inspections related to distribution and supply chain.
• Lead cross-functional teams to design initiatives impacting REMS compliance positively.
• Apply data sources to analyze and update strategies as needed.
• Oversee management of metric design and presentation of KPIs to leadership.
• Provide guidance on REMS distribution requirements and address inquiries promptly.
• Ensure audit preparedness and support regulatory inspections for REMS.
• Identify risks within REMS processes/systems and propose mitigation solutions.
• Lead the development and implementation of internal distribution-related CAPA plans.
• Support the creation, review, and investigation of Quality Records in the Quality System.

Essential Skills/Experience

• Bachelor’s degree in a scientific or business field
• 5+ years related experience in the biotechnology industry
• Distribution and supply chain experiences
• REMS experience
• GxP compliance
• Collaboration with regulatory authorities
• Leading large, cross-functional projects
• Proven, consistent history of high performance regardless of position or company
• Exceptional interpersonal skills and ability to build strong cross-functional partnerships
• Understanding of compliance regulations and guidance governing REMS
• Launch experience and/or experience in high growth areas
• High learning agility
• Experience managing people and projects
• High level of interpersonal skills and highly adept in both verbal & written communication

Desirable Skills/Experience

• MBA preferred
• Rare disease/high-value biologics experience

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.

At AstraZeneca, we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration, problem-solving, and pushing boundaries to deliver life-changing medicines. We thrive on challenges, continuously seeking new ways to improve our processes and deliver medicines efficiently to patients. Our global team is united by a common goal, fostering a positive space where ideas are welcomed and rewarded. With a focus on sustainability and ethical practices, we offer long-term opportunities for growth and development.

Ready to take on this exciting challenge? Apply now to join our team and make a difference!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.