Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is a leading biotech pharmaceutical company that combines the strength of a global organisation with the values of a family business. We specialize in the development and manufacture of high-quality pharmaceuticals derived from human blood plasma and human cell lines. 

As a Senior IT Product Owner (m/f/d) - Regulatory Information Management & electronic Documentation Management System, you will lead the implementation and own the end-to-end application lifecycle of our RIM and eDMS. You will connect Regulatory Affairs requirements with sustainable IT solutions and lead the implementation together with internal and external partners, from design through go-live and stabilisation.

The position is 100% office-based and can be based in Lachen (Switzerland) or Vienna (Austria). Relocation support is available for Vienna only.

Join us in shaping our vision of providing new health solutions advancing human life. 

Your main tasks and responsibilities 

• Lead the end-to-end implementation of RIM and eDMS, translating Regulatory Affairs needs into system requirements and coordinating business and IT stakeholders
• Ensure alignment with corporate architecture and security standards, and coordinate legacy data migration and system integrations with clear ownership of data and interfaces
• Work with Quality, Compliance, Cyber Security and Regulatory Affairs to address applicable validation and control requirements
• Manage vendors and implementation partners, monitor project risks and progress, and track decisions, deliverables and commitments
• Own the product lifecycle, roadmap and backlog after go-live, including enhancements, releases, upgrades and vendor and service performance
• Maintain documentation and the validated state, support change management and knowledge transfer, and drive practical, sustainable improvements

Your expertise and ideal skill set 

• Bachelor’s or Master’s degree in IT, Computer Science, Engineering, Life Sciences, Regulatory Affairs or a related field
• At least 7 years of experience in a regulated industry, with experience implementing or managing RIM, regulatory eDMS, Quality such as Veeva, Ennov, ArisGlobal, IQVIA, Generis, or comparable enterprise systems
• Proven ability to lead major system implementations through go-live, partner with Regulatory Affairs and manage vendors and implementation partners
• Certifications in project or product management, IT service management, validation or life sciences technology are an advantage
• Strong communication and stakeholder management skills, with the ability to connect business needs and IT solutions, take ownership and manage competing priorities

Your department - where you make an impact  

• We, the Business Applications department, are the trusted partner that drives the digital transformation of Octapharma. Together with Business, we create and deliver digital solutions to transform the organisation and improve performance. 
• We are passionate, flexible and collaborate to create value with fit for purpose solutions for Octapharma.

Thrive with us

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships 
• Be rewarded with an attractive salary and benefits package
• You will have a high level of influence where you can make a difference and leave your footprint
• Work with skilled and fun colleagues in a relatively informal organization
• Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

Additional information (Austria only):

The minimum gross salary according to the austrian collective agreement (chemical industry) is EUR 4,355.55 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.  

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.  

Do you have any questions? Then get in touch with your contact person. 

Larissa Amling 

Octapharma Pharmazeutika Produktionsges.m.b.H. 

Oberlaaer Straße 235, 1100 Wien 

Mail: larissa.amling@octapharma.com

Want to find out more about us? 

 
Visit our website Octapharma Career and follow us daily on LinkedIn.