Quality Team Lead

Vor 5 Tagen

Visp, Schweiz Bacthera Vollzeit

**Quality Team Lead (f/m/d) 100%. Visp, CH**:
Bacthera is leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

For our site in **Visp **(Switzerland) **we are seeking two dynamic, open minded and talented

**Quality Team Lead (f/m/d) 100%**:
Both team leads are member of the global Quality Assurance and Quality System team and play an essential role in the implementation of Quality capabilities to support our commercial manufacturing site. The roles ensure the guidance and hands-on Quality oversight for the GMP operation department according to the procedures and GMPs requirements. The Quality Team Lead will report to the Global Head of Quality Assurance or the Global Head of Quality System. Be part of a highly motivated and fast-growing team and shape the structure of the Quality Assurance Team or the Quality System Team.

**Role and Responsibilities**:

- Lead the Bacthera Quality Team in Visp
- Be the first contact for the manufacturing operation team within quality related issues
- 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
- lead audits or inspections
- Being responsible for the Quality Oversight of the GMP facility in Visp
- Review and approve GMP documentation
- be responsible for the electronical Quality Management System
- 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
- Built and structure a Quality Team

**Your Profile**:

- Academic or university degree in pharmacy, microbiology, biotechnology, life science
- At least 5 years relevant experience in a regulated pharmaceutical environment
- Knowledge of biopharmaceutical manufacturing
- Eligible as Responsible Person from the Swiss Health Authorities
- Strong background in GMP
- Have previous experience as a team lead within a GMP operating environment.
- 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
- Very good communication skills in English (verbal and written). German is an strong asset.

You will be based in Visp, Switzerland. Some travel can occur (e.g., to other Bacthera locations).

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