Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)

# Senior Expert - Device Project Leader - Combination Product Portfolio 3 (f/m/d) **Schaftenau** | **Full time** **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 **Skills Desired** Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model