QA Manager

vor 3 Wochen

Basel, Schweiz Panda International Vollzeit

**QA Manager - CMO - Basel - Zurich**:
**Location**
- Basel, Switzerland

**Business Sector**
- Biotechnology

**Job ref**
- 22212

**Published**
- 11 days ago

**Quality Assurance Manager - Switzerland**

Are you an experienced QA professional in Biotech? Join our client in Northern Switzerland, a prominent leader in cell & gene therapy. As a Senior QA Manager, you'll play an important role in upholding exacting quality standards, ensuring unwavering compliance with regulatory mandates, and cultivating a culture of perpetual enhancement.

**Responsibilities**:

- Lead and oversee medium and high-impact quality investigations, including root cause analysis CAPA management.
- Oversee implementation of new QMS processes
- Assume the role of change control (CC) lead for operations, guiding change control processes from initiation to successful completion.
- Provide support for process enhancements resulting from updates to materials, equipment, facility, and biotherapeutic products, including the introduction of new products.
- Serve as a Subject Matter Expert on deviations and change controls during inspections and audits.
- Ensure meticulous documentation and precise completion of quality records to maintain compliance.
- Monitor the progress of quality investigation and change control processes, tracking key performance indicators (KPIs).
- Closely cooperate with RA and QC department

**Requirements**:

- Bachelor's or Master's degree in a relevant scientific discipline, such as Biology, Chemistry, or Pharmaceutical Sciences.
- Fluent in German and English.
- Team management skills of at least 5 years.
- Experience in working with CMOs
- Background in cell and gene therapy is a plus.
- Extensive experience (5+ years) in quality assurance within the Biotech industry, with a strong understanding of GMP, GLP, CAPA, and ISO regulations.
- Experience in Regulatory Affairs is a plus.
- Willingness and ability to work on-site for a minimum of 4 days per week.
- Knowledge of machine learning algorithms is a plus.

Interested?

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