Quality System Manager

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
• 401(k) match
• Paid time off and other benefits