QMS Manager — ISO 9001, GMP & FDA Compliance

CPS Inc.; Nashville (TN); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

401k

Vacation

Full suite of insurances

Safe Harbor contribution

Tuition Reimbursement

and more!

Job summary

CPS Inc. seeks a Quality Assurance (QMS) Manager to unify QA efforts across GMP and FDA compliance, ensure ISO-9001 adherence, and manage non-conformances and supplier audits.

You will support Engineering, Commercial, and Production teams in resolving quality and technical issues, supervise QA activities, and review reports for executive leadership. Travel to multiple US sites is required.

Qualifications

• Requires hands-on quality management with ISO 9000, USP and GMP systems.
• Strong ability to analyze statistics and apply SPC/SQC in quality control.
• Experience conducting internal and external audits is essential.
• Supervisory experience in chem labs and lab personnel management.
• Proven ability to train others and lead a quality-driven culture.
• Extensive knowledge of ISO and global standards and compliance programs.

Responsibilities

• Direct the preparation and submission of all required reports to auditing and regulating agencies.
• Prepare customer and internal quality complaint reports as required by management.
• Review and approve monthly quality reports from all facilities for executive leadership.
• Lead investigations into customer complaints and non-conformances; coordinate external investigations when needed.
• Travel to customer sites to review operations and product requirements.
• Develop and execute an annual supplier audit schedule (paper, virtual, in-person).
• Partner with customers to integrate company product into their processes.
• Support investigations into customer applications and instrument issues.
• Conduct quarterly compliance audits for US facilities.
• Complete customer quality surveys and serve as the audit contact for US facilities.
• Monitor production data to ensure compliance with quality regulations.
• Authorize release of API-grade products when needed by the QC manager.

Skills

Quality management

Statistics & SPC

Audits

Lab supervision

Training

ISO standards

Non-conformance handling

Travel readiness

Education

Bachelor’s degree in Engineering or Chemistry

Job description

CPS Inc. seeks a Quality Assurance (QMS) Manager to unify QA efforts across GMP and FDA compliance, ensure ISO-9001 adherence, and manage non-conformances and supplier audits.

You will support Engineering, Commercial, and Production teams in resolving quality and technical issues, supervise QA activities, and review reports for executive leadership. Travel to multiple US sites is required.