Senior Expert - Device Project Leader - Combination Product Portfolio 3 (f/m/d)

Band

Level 4

 

Job Description Summary

With the increasing diversity of Novartis' portfolio, the need for driving our drug-device combination product portfolio is also increasing. As such, we are searching for a Senior Expert – Device Project Leader for joining our team in Schaftenau in the Portfolio & Customer Center within Global Device and Packaging Development.

In the role of Senior Expert – Device Project Leader, you will be a vital part of the Portfolio & Customer Center within the Global Device and Packaging Development (GDPD) team based in Schaftenau/AT. Your primary responsibility is to guide and manage cross-functional project teams both within and outside of the GDPD. This includes representing GDPD in the CMC sub-teams, leading relevant discussions, gaining support, and securing approval for project strategy and changes.

 

Job Description

Key Responsibilities:  
Your responsibilities include but are not limited to: 

• Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes.  

• Lead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues. 

• Plan, manage, and control project resources, schedules, and budgets.  

• Assess and negotiate internal & external resource needs on an ongoing basis. Establish and maintain a high-quality Design History File for developments and LCM projects until transfer to manufacturing sites.  

• Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements.  

• Contribute to the improvement of process and delivery technology approaches.  

• Evaluate suitable device technology to support different project phases.  

• Support internal and external audits on packaging and medical device related matters. 

• Assist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries. 

Essential Requirements:  

•  Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent. 

• Minimum 2-4 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development including technical operations. 

• Ability to work and lead a cross-functional team in a matrix environment 

• Proven knowledge and track record in project and program planning and execution 

• Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and current good manufacturing practices (cGMP). 

• Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker. 

• Fluent in English (oral and writing), German is beneficial 

 
Why Novartis?  
Our purpose is to reimagine medicine to improve and extend people’s lives and ou