Quality Assurance Manager

• Ensure documentation supporting site quality processes is clear, compliant, and acceptable for use in a GMP testing environment
• Drive deviations, non-conformities, OOS investigations to closure and ensure adherence to procedures; this includes but is not limited to ensuring effective root cause analysis has been conducted, collaborating with stakeholders on suitable corrective and preventive actions, and ensuring that conclusions are supported with adequate information and a clear rationale
• Own and coordinate or act in approver capacity for change controls
• Support GMP training for peers and stakeholder teams
• Monitor and report on metrics and KPIs; collaborate with stakeholders to improve quality process efficiency and effectiveness
• Support the Quality Assurance organization in the coordination of, preparation for, and follow up on internal and external audits and inspections

• Bachelor in Life Sciences with 5+ years relevant experience in a quality-facing role (or equivalent combination of education and experience)
• Experience working in GMP testing environment
• Experience in processing quality events (i.e., deviations, laboratory non-conformities, OOS/OOT/OOE investigations, CAPAs, change controls) per applicable operating procedures
• Experience supporting internal or external audits and health authority inspections
• Working with QMS (e.g., Master Control) and LIMS (e.g., Labware) IT systems
• Have a developing subject matter expertise in one of the following areas of the QMS: controlled document management, GMP training program management, data integrity program management, audit/inspection management
• Excellent organizational skills and ability to work and make decisions independently
• Strong written and verbal communication skills
• Fluency in English and willingness to learn German is required

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards