Quality Assurance Manager
Descrizione dell'offerta
Our client is a preclinical stage biotech company pioneering inhalable cardiovascular treatments via non-viral nano-delivery of biologics.
The Company is devoted to the clinical development of an innovative proprietary platform for tissue-directed delivery of therapeutic peptides and RNAs.
Its core vehicle is an inorganic calcium-phosphate nanoparticle, a versatile, biomimetic nano-carrier that can be loaded or surface-decorated with biologics and formulated for inhalation or other administration routes.
If you are motivated by science with impact, regulatory excellence, and the opportunity to build quality systems in a cutting-edge biotech environment, this could be your next career step.
The Role
As Quality Assurance Manager , you will play a central role in shaping, maintaining and strengthening the company’s Quality Management System.
You will work across departments, ensuring compliance, driving continuous improvement and supporting the transition toward clinical development.
This is not just a maintenance role, it is a build-and-evolve opportunity within an ambitious biotech start-up.
Key Responsibilities
- Lead and oversee lot release, investigations, change control and CAPA processes
- Provide QA support to laboratories and facilities
- Implement, develop and continuously improve SOPs and QMS
- Ensure compliance with applicable GxP regulations and industry standards
- Identify quality risks and implement mitigation strategies
- Manage internal and external audits, regulatory inspections and vendor qualification
- Monitor quality metrics and identify compliance gaps
- Support cross-functional teams and promote a strong quality culture
- Contribute to documentation governance and record management
- Support budget and resource planning within QA activities
Who We Are Looking For
We are looking for a professional who combines regulatory rigor with a pragmatic, solution-oriented mindset .
You likely bring:
- A degree in Industrial Biotechnology, Biological Sciences, Chemistry, Pharmacy or related disciplines
- Solid experience in Quality Assurance within biotech, pharma or advanced life science environments
- Hands-on knowledge of QMS, SOP development, change control, deviations and CAPA
- Experience with audits and regulatory interactions
- Ability to work cross-functionally in a dynamic, evolving organization
- Strong analytical and documentation skills
Experience in early-stage or rapidly growing biotech environments will be considered a plus.
Why Join
- Work on a first-in-class nano-delivery platform
- Be part of a high-scientific, innovation-driven environment
- Contribute directly to the transition toward clinical development
- Take ownership and shape the quality infrastructure of a growing biotech company
- Join a team where scientific excellence meets entrepreneurial spirit