Quality Systems Assessment Specialist

A brief overview

This position supports daily Quality Management System (QMS) activities, including internal audits, customer and regulatory inspections, audit observation management, quality records, management review documentation, CAPA and deviation investigations, quality planning, and project execution. The incumbent serves as a subject matter expert and leads continuous improvement initiatives while supporting the development, maintenance, and oversight of Quality Systems across Bachem U.S. sites. Working closely with QA and cross-functional teams in the U.S. and Europe, this individual helps implement and maintain quality system workflows, including audit management, complaint handling, and CAPA processes. Responsibilities also include eQMS administration, user training, system support, quality metrics reporting, inspection readiness activities, and conducting audits on behalf of Bachem Americas sites.

What you will do

• Lead and support quality systems projects and continuous improvement initiatives.
• Plan, conduct, and support internal, customer, and supplier audits.
• Ensure a GMP-compliant, effective, and efficient global Quality Management System (QMS).
• Administer, maintain, and continuously improve Bachem's electronic Quality Management System (eQMS).
• Implement, document, and validate system enhancements, configurations, and data migrations.
• Lead and support quality event investigations, root cause analyses, and corrective actions.
• Gather, analyze, and document business requirements for new eQMS functionality and process enhancements.
• Collect, analyze, and report quality data and metrics, including Quality System Management Reviews (QSMRs).
• Support regulatory inspections, customer audits, and internal audit programs to ensure ongoing compliance.

Qualifications

• Bachelor's Degree in a natural science (Chemistry, Process Engineering, Pharmacy, Food Technology or similar field) or BSc degree with equivalent professional experience required
• Master and/or PhD with an area of focus in a natural science (Chemistry, Process Engineering, Pharmacy, Food Technology or similar field preferred
• 7-9 years of experience in quality system management activities required
• 7-9 years Training in configuration of database supported software systems for process digitalization (e.g. ERP, DMS, QMS, LIMS, etc) required
• Experience failure investigation and root cause analysis for processing and evaluation of quality events
• Experience in dealing with customers and authorities
• Experience in hosting and conducting inspections
• Basic knowledge of leadership tasks (lateral leadership)
• strong knowledge of matric planning, development and roll out
• Solid knowledge of MS Office / Teams / Excel & PowerPoint / Project planning tool
• Experience in dealing with electronic management systems and harmonization across multi-site facilities.
• Lead or internal audit certification required
• ASQ certification or equivalent required