Global QMS & Quality Systems Lead — Audits & CAPA

Bachem Holding AG; Vista, Northern (CA, KY); Hybrid; USD 91,000 - 126,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation and sick days

Job summary

Bachem Americas is seeking a Quality Systems Manager to lead QMS projects and continuous improvement at U.S. sites. You will collaborate with QA and cross-functional teams in the U.S. and Europe to implement and maintain robust quality workflows, audits, CAPA, and data-driven improvements.

The role requires strong experience in audits, eQMS, and quality metrics, plus ASQ certification, with a focus on regulatory readiness and inspections. Competitive rewards are offered.

Qualifications

• Bachelor's degree in a natural science (Chemistry, Process Engineering, Pharmacy, Food Technology or similar) or BSc with equivalent experience.
• Master and/or PhD in a natural science preferred.
• 7-9 years of quality system management experience.
• Experience configuring database-supported software systems for process digitalization (e.g. ERP, DMS, QMS, LIMS).
• Experience in failure investigations and root cause analysis for quality events.
• Experience interacting with customers and authorities.
• Audits hosting and inspections experience.
• ASQ certification or equivalent required.

Responsibilities

• Lead and support quality systems projects and continuous improvement initiatives.
• Plan, conduct, and support internal, customer, and supplier audits.
• Ensure a GMP-compliant, global QMS.
• Administer, maintain, and improve the eQMS.
• Implement, document, validate enhancements and data migrations.
• Lead quality event investigations and CAPA actions.
• Gather and document requirements for new eQMS functionality.
• Collect and report quality data and metrics, including QSMRs.
• Support regulatory inspections and audit programs.

Skills

Quality management

Audits

CAPA

Root cause analysis

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in natural science

Master's or PhD in natural science

Tools

eQMS

MS Office

Excel

PowerPoint

Teams

Project planning tool

Job description

Bachem Americas is seeking a Quality Systems Manager to lead QMS projects and continuous improvement at U.S. sites. You will collaborate with QA and cross-functional teams in the U.S. and Europe to implement and maintain robust quality workflows, audits, CAPA, and data-driven improvements.

The role requires strong experience in audits, eQMS, and quality metrics, plus ASQ certification, with a focus on regulatory readiness and inspections. Competitive rewards are offered.