QA Product Lead — GMP/Regulatory QA Expert (Flexible)

ten23 health; Oberwallis; Remote; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Career development

Flexible working arrangements

Training options

Competitive pension plan

Annual bonus

Zusammenfassung

ten23 health in Visp, Switzerland, seeks two QA Product Leads to drive quality across project lifecycles. You will act as the main QA contact for customers and internal teams, ensuring GMP-compliant product development, manufacturing, and QC release processes.

The role requires 8+ years in technical QA, strong GMP knowledge, experience in sterile drug product operations, and fluent German and English to support cross-functional collaboration with regulators and customers.

Qualifikationen

• Bachelor's or Master's in Biochemistry, Biotechnology, Pharmacy, or related field.
• Minimum 8 years in a technical QA role.
• Experience in Drug Product manufacturing and aseptic operations.
• Strong GMP understanding in sterile pharmaceutical production.
• Fluency in German and English for technical communication.
• Independent with strong cross-functional collaboration.

Aufgaben

• Act as the primary technical QA representative in customer projects.
• Provide QA oversight across all phases, ensuring GMP compliance.
• Review product quality records (DEV, CAPA, CR) for accuracy and compliance.
• Execute Quality Agreement activities with customers.
• Provide technical input for method transfer and qualification/validation activities.
• Oversee batch records and support batch release.
• Serve as SME during customer audits and health authority inspections.
• Support regulatory submissions with Regulatory Experts.

Kenntnisse

QA leadership

GMP knowledge

Sterile production

Technical writing

Cross-functional teamwork

Regulatory submissions

Ausbildung

Bachelor's degree in Biochemistry

Master's degree in Biotechnology

Tools

LIMS

Electronic Batch Records

MS Office

Jobbeschreibung

ten23 health in Visp, Switzerland, seeks two QA Product Leads to drive quality across project lifecycles. You will act as the main QA contact for customers and internal teams, ensuring GMP-compliant product development, manufacturing, and QC release processes.

The role requires 8+ years in technical QA, strong GMP knowledge, experience in sterile drug product operations, and fluent German and English to support cross-functional collaboration with regulators and customers.