Serialization Manager / Serialization System Owner (m/f/d)
Serialization Manager / Serialization System Owner (m/f/d)
Serialization Manager / Serialization System Owner (m/f/d)
Serialization Manager / Serialization System Owner (m/f/d)
AOP Orphan Pharmaceuticals GmbH
Pharmazeutische Produkte, Arzneimittel
Wien
- Art der Beschäftigung: Vollzeit
- 54.500 € – 76.000 € (von XING geschätzt)
- Vor Ort
- Zu den Ersten gehören
Serialization Manager / Serialization System Owner (m/f/d)
Über diesen Job
Serialization Manager / Serialization System Owner (m/f/d)
Full-time Vienna
As
Serialization Manager / Serialization System Owner
, you will have
end-to-end responsibility for our serialization systems and processes
.
You will ensure stable, GMP-compliant system operations and act as a
key interface between IT, Quality, Packaging, external partners, and regulatory authorities
, supporting global market requirements.
What Your Day To Day Will Look Like
What Your Day To Day Will Look Like
Act as System Owner for serialization-related IT systems (e.g. Avarto, Melior, LSPedia)
Ensure compliant system operation in a GMP environment, including:
- SOP management
- Change control
- Validation activities
- Periodic reviews
- User and access management
- Onboarding activities
- Manage connectivity to regulatory hubs and authorities (e.g. EU-Hub / EMVO, DSCSA)
- Coordinate serial number and master data exchange with authorities, CMOs, and wholesalers
- Administer products, SKUs, and product catalogs (e.g. GS1 standards, BrandSync)
- Support onboarding of new products and markets (e.g. GCC, US, LATAM)
- Implement system changes in collaboration with internal stakeholders and external vendors
- Support serialization-related projects and regulatory implementations
- Handle serialization alerts and support QA investigations and incident reporting
- Manage serialization-related fees and annual agreements with NMVOs
- Act as the primary point of contact for serialization topics for internal and external stakeholders
Your
Qualifications and Experience
Your Qualifications and Experience
-
Bachelor’s degree in Natural Sciences, Business Administration, Information Technology or a related field
or comparable professional experience as a key user or system owner in complex IT environments - Several years of experience with serialization systems or secondary packaging automation in a GMP-regulated environment
- Strong knowledge of pharmaceutical serialization regulations (EU FMD; DSCSA is an advantage)
- Confident handling of complex IT systems and interfaces
- Structured, precise, and independent working style
- Strong analytical and problem-solving skills
- Ability to clearly communicate technical and regulatory topics to diverse stakeholders
- High level of reliability and resilience in a regulated environment
- Very good English skills; additional languages are an advantage
Our Offer
Our Offer
- An open corporate culture with the opportunity to contribute your own ideas
- Working independently in a collegial and committed team
- Modern working environment with good public transport connections (U4 - Heiligenstadt)
- Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
- Structured onboarding and support through a buddy system
- Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 54.642 gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.
If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE and