QA Manager (f/m/d) 100% – Hørsholm, DK
We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.
Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organisation (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.
For our site in Hørsholm, Denmark we are seeking a motivated person to be part of our QA organization as a:
QA Manager (f/m/d) 100%
The QA Manager is a member of the Quality Assurance Team and plays an essential role in the implementation of Quality capabilities to support our clinical manufacturing site. The applicant ensures the guidance and hands-on Quality oversight for the GMP operation department and the development department’s according to the procedures and GMPs requirements. The applicant will report to the Head of Quality Assurance.
- Academic or university degree in pharmacy, microbiology, biotechnology, life science
- At least 3 years relevant experience in a regulated pharmaceutical quality assurance
- Knowledge of biopharmaceutical clinical trial manufacturing and the requirements for the different clinical phases
- Strong background in GMP is an asset
- Structured, focused and well-organized working attitude
- Being agile, highly motivated and dynamic drive is needed in this fast-paced environment
- Motivated to move topics forward and bring it to an end and deliver the right quality
- Good skills in communication and connection between interfaces, within organizations and sites
- Knowledge in LEAN principles is an advantage
- Very good communication skills in English (verbal and written)
Role and Responsibilities
- Support the development of the company’s overall quality strategy
- Establish, implement, maintain and monitor the processes for e.g. Document Management, Change Control, Deviation and CAPA Management.
- Perform regular assessments of the compliance and effectiveness of the Quality System requirements and report the results to the management
- Conduct internal audits or supplier audits
- Being responsible for the Quality Oversight of the GMP facility in Hørsholm
- Review and release process intermediates
- Review and approve GMP documentation
- Ensures an effective information exchange/ flow to other departments or interfaces
- Advise and guide personnel in GMP topics or issues
- Perform GMP trainings on site
- Asist in Health Authority Inspection as Quality SME or in the organization of the inspection
Are you interested to work for an innovative, dynamic and future oriented start-up company? If you are looking for a new challenging role were you can create things and leave your footprint then send us your full application to Ms. Sandra Gamboni, Head of Human Resources; email@example.com.
We are looking forward to welcome you in our new offices in the Business Center in Hørsholm.