|Published||21 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.
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
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.
If you meet these requirements and possess any of the additional qualifications mentioned above, please feel free to send me a message and your CV at email@example.com.