Quality Systems Assessment Specialist

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

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.

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

Annual Salary

Range: $91,280 - $125,510 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.