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

Links

Kontakt für Anpassungen

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

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

Novartis Pharma GmbH

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

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

Hauptstandort

Novartis Pharma GmbH

Novartis Pharma GmbH

Hauptstandort

pharmakarriere.at

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