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

Novartis
Schaftenau
ab 65.605 / Jahr

You lead device project initiatives, managing resources and ensuring compliance while supporting regulatory preparations and audits. Your role facilitates effective communication and aligns project strategies across teams.

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 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 project phases.
  • •Support internal and external audits on packaging matters.
  • •Assist in preparing regulatory dossiers for medical devices.

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 **Basel (City)** | **Full time** **Job Description Summary** Location: Schaftenau, Austria Hybrid Working #LI-Hybrid Role Purpose: 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:** * 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**
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