Project Manager – Drug Handling License (part-time)
Haselmeier Czech Republic (HMCZ), part of the medmix group, is expanding its activities in the field of medical devices and combination products. To support this strategic development, we are looking for an experienced Project Manager to lead the implementation and approval of a Drug Handling License (Manufacturing Authorisation according to article 40 of Directive 2001/83/EC) in the Czech Republic.
The role is designed as a project-based, part-time position (up to 0.4 FTE), with the possibility of continuation in case of successful delivery and launch of further expansion projects.
- Lead and deliver the project to obtain the Drug Handling License from the Czech authority (SÚKL)
- Prepare, coordinate and submit all required documentation for the license application
- Actively communicate with SÚKL and manage all regulatory interactions related to the approval
- Collaborate with the Drug Delivery Quality and RA team in Stuttgart to set-up a site GMP concept aligned with global drug delivery and healthcare standards
- Analyze existing Haselmeier processes (especially from German sites) and adapt them to Czech regulatory, process and infrastructure requirements
- Create, review and implement SOPs, work instructions, process maps and records related to drug handling
- Coordinate activities across Quality, Operations, Regulatory Affairs and Engineering teams
- Actively collaborate with colleagues in Germany (Buchen, Stuttgart) and transfer best practices to HMCZ
- Support preparation for inspections and audits related to the Drug Handling License
Qualifications
- Secondary or university degree; degree in pharmacy, veterinary medicine, chemistry, pharmaceutical technology, biology or related fields is a strong advantage
- Proven experience in project management, preferably in a regulated environment
- Experience in pharmaceutical, biotech or medical device industry is a strong advantage (quality field is minimum requirement)
- Solid understanding of EU and Czech GMP regulatory requirements for pharmaceuticals, experience with combination products is a plus
- Ability to translate complex regulatory and quality requirements into structured project execution
- Strong organizational and communication skills
- High level of reliability, accuracy and proactive mindset
- Fluent Czech (C1/C2), English at minimum B2 level (active communication with international teams)
- Good working knowledge of MS Office
Additional Information
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