Quality System Manager

Mackenzie Stuart; Town of Florida (NY); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Bonus structure

Job summary

Mackenzie Stuart is recruiting for a US-based client seeking a Quality Manager to lead the Quality department, ensuring products meet customer specs, regulations and internal policies.

The ideal candidate has 5+ years QA/QC in dietary supplements or regulated fields, deep knowledge of 21 CFR Part 111 and NSF certification, and strong leadership and communication skills.

Qualifications

• 5+ years QA/QC in dietary supplements or regulated industry.
• Knowledge of 21 CFR Part 111 and NSF certification.
• Strong leadership and communication skills.

Responsibilities

• Oversee daily workflow of QA/QC department.
• Train and evaluate performance of QA and QC personnel (2 direct reports).
• Coordinate internal and external product testing and quality workflows.
• Communicate quality standards across QC, QA, production and other related departments.
• Authorize production stoppages to prevent quality risks.
• Monitor production records and ensure accurate documentation.
• Maintain compliance with 21 CFR Part 111 cGMPs for dietary supplements.
• Oversee Master Manufacturing Records, Batch Production Records, batch review and finished-product release.
• Manage deviations, investigations, CAPAs, change controls, supplier and raw material qualifications.
• Oversee complaints, stability programs and environmental and production controls.
• Maintain SOPs, document control, training and FDA inspection readiness.
• Conduct or oversee internal audits, mock recalls and customer or third-party audits.
• Implement and maintain NSF certification requirements.
• Verify correct raw materials, weighing and documentation in LM and PB rooms.
• Review customer and user feedback and ensure corrective action where required.

Skills

QA/QC experience

Regulatory knowledge

Leadership / management

Communication

Analytical skills

QMS software

Tools

Isolocity

QMS software

Google Workspace

Microsoft Office

Job description

Our client is a US-based CDMO supporting nutraceutical companies with the development and manufacturing of dietary supplements in the form of powders, capsules, tablets and liquids. They are seeking a Quality Manager to lead their Quality department and ensure that all products meet customer specifications, government regulations and company policies.

Key responsibilities:

• Oversee the daily workflow of the department
• Train and evaluate performance of QA and QC personnel (currently 2 direct reports)
• Coordinate internal and external product testing and quality workflows
• Communicate quality standards across QC, QA, production and other related departments
• Authorise production stoppages where necessary to prevent quality risks
• Monitor production records and ensure accurate documentation
• Maintain compliance with applicable regulations, including 21 CFR Part 111 dietary supplement cGMPs
• Oversee Master Manufacturing Records, Batch Production Records, batch review and finished-product release
• Manage deviations, investigations, CAPAs, change controls, supplier and raw material qualifications
• Oversee complaints, stability programs and environmental and production controls
• Maintain SOPs, document control, training and FDA inspection readiness
• Conduct or oversee internal audits, mock recalls and customer or third-party audits
• Implement and maintain NSF certification requirements
• Verify correct raw materials, weighing and documentation in the LM and PB rooms
• Review customer and user feedback and ensure corrective action where required

The ideal candidate:

• Min. 5+ years QA/QC experience in the dietary supplement or a similarly regulated industry, with a strong preference for management experience
• Extensive understanding of regulations relevant to nutraceuticals manufacturing, especially 21 CFR Part 111 and experience with NSF certification
• Excellent interpersonal, verbal and written communication skills
• Excellent analytical skills and a strong attention to detail
• Strong preference for management experience, or proof of strong supervisory and leadership skills
• Proficiency with Google Suite, Microsoft Office Suite, Isolocity and other QMS software

Compensation:

• Highly competitive salary and bonus structure, flexible dependent on experience