Quality Systems Assessment Specialist

Bachem Holding AG; Vista, Northern (CA, KY); On-site; 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

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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.