Director of Quality Systems

Job Description

Job Description

Summary

The Director of Quality Systems is responsible for the leadership, development, implementation, and ongoing effectiveness of the Company’s Quality Management System (QMS), supporting dietary supplement manufacturing, laboratory operations, and third-party/contract manufacturing activities. This position provides strategic and operational Quality leadership to ensure products are manufactured, tested, packaged, labeled, held, and distributed in accordance with established specifications, company procedures, and applicable regulatory requirements, including 21 CFR Part 111 and 117 Current Good Manufacturing Practice (cGMP) for Dietary Supplements.

Key Responsibilities

• Lead, develop, implement, and maintain the Company’s Quality Management System (QMS) in accordance with 21 CFR Part 111 and 117, applicable cGMP requirements, established specifications, and company procedures.
• Provide Quality leadership and oversight of manufacturing operations, ensuring appropriate controls are maintained from raw material receipt through manufacturing, packaging, testing, product release, storage, and distribution.
• Provide leadership and oversight of Quality Control laboratory operations, including analytical and microbiological testing, laboratory investigations, method suitability, equipment qualification/calibration, data integrity, and testing timelines.
• Manage Quality oversight of third-party/contract manufacturers, contract laboratories, and critical suppliers, including qualification, audits, Quality Agreements, performance monitoring, investigations, CAPAs, and change notifications.
• Ensure appropriate specifications, testing requirements, and acceptance criteria are established and maintained for components, raw materials, in-process materials, bulk products, packaging materials, labels, and finished products.
• Oversee product review, approval/rejection, and release activities, ensuring required manufacturing documentation, laboratory testing, investigations, and Quality requirements are satisfactorily completed prior to disposition.
• Lead and oversee deviations, nonconformances, OOS/OOT investigations, CAPAs, change controls, complaints, and other quality events, ensuring appropriate root-cause analysis, risk assessment, corrective actions, and timely closure.
• Establish, monitor, and report Quality KPIs, metrics, and trends to identify compliance risks, recurring issues, operational performance concerns, and opportunities for continuous improvement.
• Oversee key Quality systems, including document control, SOP management, cGMP training, supplier qualification, returned goods, reserve samples, complaints, and record retention.
• Ensure appropriate Quality oversight of Master Manufacturing Records (MMRs), Batch Production Records (BPRs), specifications, laboratory records, and other documentation required to demonstrate compliance with 21 CFR Part 111.
• Ensure Quality Control responsibilities for the approval or rejection of components, packaging, labels, in-process materials, and finished products are appropriately executed and documented.
• Provide Quality oversight for equipment qualification, calibration, validation, cleaning and sanitation programs, environmental monitoring, and other manufacturing or laboratory systems impacting product quality.
• Lead Quality activities associated with FDA inspections, regulatory inspections, customer audits, supplier/contract manufacturer audits, and third-party certification audits, including preparation, responses, CAPAs, and follow-up activities.
• Maintain an effective internal audit and inspection-readiness program to proactively identify and address potential compliance gaps.
• Partner with Manufacturing, Laboratory, Regulatory, Operations, Procurement, Supply Chain, Engineering, and Product Development to ensure Quality and regulatory requirements are incorporated into operational and business decisions.
• Provide leadership, coaching, and development to Quality and Laboratory personnel, establishing clear expectations, accountability, technical competency, and a strong culture of cGMP compliance.
• Identify and evaluate Quality, product, manufacturing, laboratory, and compliance risks, develop practical and scientifically sound solutions, and drive issues through timely and effective resolution.
• Promote continuous improvement of Quality systems and operational processes while maintaining product quality, consumer safety, regulatory compliance, and business continuity.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in quality management, life sciences, bio-medical engineering, business, or appropriate equivalent from an accredited university preferred.
• Minimum of 10 years of hands-on work experience in a related industry; dietary supplement or consumer products industries required.
• Must have strong working knowledge of applicable cGMP guidelines and 21CFR 110 , 111 and 117.
• Strong computer skills, including Microsoft business applications and various reporting software.
• Must have strong project management, business writing, and reporting skills.
• Excellent written and verbal communication skills.
• Ability to read, analyze, and interpret standard information, reports, and other documentation.
• Understand state and federal requirements for manufacturing, distribution, marketing, and sale of consumer products.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, and/or company representatives.
• Ability to effectively present information to management and work cross-functionally across all levels of the organization and with external manufacturing and distribution partners.
• Ability to perform multiple tasks simultaneously, keep accurate records.

Physical/Work Environment/Expectations

While performing duties of job, the incumbent is occasionally required to:

• Operate in a professional office environment.
• Constantly use work-related equipment.
• To use hands and fingers to handle or feel objects, tools, or controls.
• Occasionally lift and/or move up to 25 pounds.
• To sit for long periods of time (up to 10 hours per day).
• To lift files, open filing cabinets and bend or stand as necessary.
• Ability to work regular, full-time schedule, Monday through Friday with the flexibility to work additional hours depending on business demands.

Note: This job description is not totally inclusive nor is it designed to cover or contain a complete comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.