Senior Expert - Device Project Leader (f/m/d)

Standort: Schaftenau, Österreich (Tirol) | Unternehmen: AT33 Novartis Pharmaceutical Manufacturing GmbH | Bereich: Research & Development | Anstellung: Vollzeit, Regular

Summary

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

About the Role – Key responsibilities

• Represent GDPD in CMC sub-teams, lead device-related discussions and secure endorsement for project strategy or changes.
• Lead cross-functional project teams; act as single point of contact (SPOC) for device & packaging topics.
• Plan, manage and control project resources, schedules and budgets.
• Assess and negotiate internal & external resource needs on an ongoing basis.
• Establish and maintain high-quality Design History Files for development and LCM projects until transfer to manufacturing sites.
• Ensure compliance with Design Control, CMC, FDA combination product regulations and relevant ISO requirements.
• Contribute to process and delivery technology improvements; evaluate suitable device technologies.
• Support internal and external audits on packaging and medical device matters.
• Assist teams in preparing regulatory dossiers and responses to health authority queries.

Essential Requirements

• Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.
• 2–4 years experience in the pharmaceutical industry, preferably in drug-device combination product technical development incl. technical operations.
• Ability to lead cross-functional teams in a matrix environment.
• Proven project/program planning and execution track record.
• Knowledge of regulatory guidelines for combination products incl. relevant ISOs and cGMP.
• Collaborative, self-driven, high learning agility; good listening skills; strategic thinker.
• Fluent English (oral/written); German beneficial.

Benefits

Market-competitive base salary, attractive incentive program, modern pension scheme, childcare facilities, learning & development, and global career opportunities.
Austrian legal minimum (full-time): EUR 65,605.54 per year; actual salary higher depending on experience and qualifications.

Weitere Informationen

Division: Development | Business Unit: Innovative Medicines | Functional Area: Research & Development | Site: Schaftenau | Shift Work: No

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Kontakt für Anpassungen

Adjustments for Applicants with Disabilities (Austria): disabilities.austria@novartis.com