Global QMS & Audit Lead — CAPA & Compliance

Bachem; Vista (CA); On-site; USD 91,000 - 126,000; Full time

Job summary

Bachem Americas is seeking a qualified quality systems lead to support daily QMS activities across U.S. sites. You will drive audits, CAPA investigations, and system improvements in collaboration with QA and cross-functional teams in the U.S. and Europe.

The role emphasizes eQMS administration, inspection readiness, and metrics reporting, with opportunities to influence global quality processes and regulatory readiness.

Qualifications

• Bachelor's Degree in a natural science or BSc with equivalent professional experience.
• Master and/or PhD with focus in natural science preferred.
• 7-9 years of quality system management experience.
• 7-9 years training in configuration of database supported software systems (ERP, DMS, QMS, LIMS)
• Experience in failure investigations and root cause analysis for quality events
• Experience in dealing with customers and authorities
• Experience in hosting and conducting inspections
• Lateral leadership knowledge
• Strong knowledge of matrix planning, development and rollout
• Proficient in MS Office / Teams / Excel & PowerPoint / project planning tools
• Experience with electronic management systems and harmonization across multi-site facilities
• Lead or internal audit certification required
• ASQ certification or equivalent required

Responsibilities

• Lead and manage quality systems projects and continuous improvement initiatives.
• Plan, conduct, and support internal, customer, and supplier audits.
• Ensure a GMP-compliant, effective global QMS.
• Administer and improve the eQMS.
• Implement, validate, and migrate system enhancements.
• Lead investigation and root cause analyses for quality events.
• Gather and document business requirements for new eQMS functionality.
• Collect and report quality data and metrics, including QSMRs.
• Support regulatory inspections, customer audits, and internal audit programs

Skills

Quality management

Audits

CAPA investigations

Root cause analysis

Quality metrics reporting

eQMS administration

Cross-functional collaboration

Education

Bachelor's Degree in natural science

Master's or PhD in natural science

Audit certification

ASQ certification

Tools

ERP

DMS

QMS

LIMS

Job description

Bachem Americas is seeking a qualified quality systems lead to support daily QMS activities across U.S. sites. You will drive audits, CAPA investigations, and system improvements in collaboration with QA and cross-functional teams in the U.S. and Europe.

The role emphasizes eQMS administration, inspection readiness, and metrics reporting, with opportunities to influence global quality processes and regulatory readiness.