Information Systems Strategic Lead - Early Product Development & Manufacturing

About this role

Responsibilities

• Join EPDM to lead the strategic direction and continuous improvement of integrated IS/IT/OT applications and systems that enable GMP operations in Gothenburg. This is a senior, hands‑on strategic role with no direct reports, requiring strong people leadership to drive compliance, performance, and innovation across environmental monitoring, planning, batch data, mechatronics and advanced process automation. The role is focused on ensuring that EPDM develops knowledge and drive development of current and future IS/IT/OT solutions, impacting quality and speed of our operation. This role is located at our strategic R&D site in
• Gothenburg, Sweden
• .
• Your core responsibilities will include:
• Lead strategy, planning, and continuous improvement of complex IT and equipment systems, assuring License to Operate and long-term capability.
• Build EPDM’s expertise in computerized system validation, upskilling teams and embedding robust validation practices. Prepare documents and present at quality audits.
• Define and improve system function and up-time through backup and recovery, service management, and future IS/IT/OT infrastructure in partnership with IS leads, IT, and vendors.
• Lead GMP system projects from concept to implementation, coordinating change without impacting critical production paths.
• Act as system owner where needed; partner with system managers to maintain validated status, resolve issues, and deliver enhancements.
• Own lifecycle management, business continuity and disaster recovery planning for relevant systems.
• Drive incident/quality event management and deliver enhancements aligned to evolving business processes and external manufacturing trends.
• Coach and mentor staff, share best practice, and develop training and competence.
• Collaborate across Pharm Sci, PT&D, IT, FM, Dev Q, and external partners; represent EPDM with suppliers and industry stakeholders.
• Essential requirements for the role
• Master’s degree in chemistry, engineering, IS/IT, or related discipline; 10+ years of experience with IS/IT/OT application ideally in the pharmaceutical industry.
• Excellent strategic thinking, communication, and stakeholder management skills - with the ability to influence scientific, data, and technical partners across the organisation.
• Proven leadership and team working skills; track record delivering complex projects and implementing new functionality.
• Demonstrated ability to lead and coach individuals and teams in a culturally diverse, complex and changing environment.
• Strong knowledge of cGMP, SHE, and IT QMS; deep understanding of IS/IT/OT applications, including service management.
• Excellent documentation and communication in English (Swedish a plus).
• Why AstraZeneca
• At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. Ultimately, it’s more than a job. We know that our work impacts people with serious conditions, many of whom have no other alternatives. That’s what drives us – the potential to impact over one billion patients worldwide.
• So, what’s next?
• We look forward to receiving your application (CV and cover letter) no later than
• May 17th, 2026.
• Please combine your cover letter and CV into a single document before uploading.
• Date Posted
• 08-May-2026
• Closing Date
• 17-May-2026
• 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.