You lead device project initiatives, managing resources and ensuring compliance while supporting regulatory preparations and audits. Your role involves coordinating discussions and enhancing processes throughout the project phases.
Anforderungen
- •Master or PhD in natural science preferred
- •Minimum 2-4 years in pharmaceutical industry
- •Ability to lead cross-functional teams
- •Proven knowledge in project planning
- •Understanding of regulatory guidelines
- •Collaborative spirit and self-driven attitude
- •Fluent in English, German is beneficial
Deine Aufgaben
- •Represent GDPD in CMC sub-teams.
- •Lead device-related discussions and secure project strategy endorsements.
- •Act as SPOC for device and packaging issues.
- •Plan and manage project resources, schedules, and budgets.
- •Assess and negotiate resource needs continuously.
- •Establish and maintain a Design History File.
- •Ensure compliance with internal processes and regulations.
- •Contribute to process and delivery technology improvements.
- •Evaluate device technology for various project phases.
- •Support internal and external audits on packaging matters.
- •Assist in preparing regulatory dossiers and responding to queries.
Deine Vorteile
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
Original Beschreibung
# Senior Expert - Device Project Leader - Combination Product Portfolio 3 (f/m/d)
**Schaftenau** | **Full time**
**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