Find & Apply For Quality Control Systems Manager Jobs in Independence, Missouri

Director of Quality Executive leadership role responsible for the quality management system, product quality, regulatory compliance, and continuous improvement.

DEPARTMENT

Quality

REPORTS TO

Chief Operations Officer

CLASSIFICATION

Exempt

LOCATION

[Insert Location]

EFFECTIVE DATE

[Insert Date]

DIRECT REPORTS

Quality Assurance, Quality Control, Compliance, and related quality functions Position Summary The Director of Quality provides strategic and hands-on leadership for the company's Quality Management System (QMS) and all Quality Assurance, Quality Control, compliance, and business excellence activities. The role has authority and responsibility to ensure that materials, manufacturing processes, facilities, records, and finished products meet established specifications, current Good Manufacturing Practice (cGMP) requirements, customer expectations, and applicable regulatory and certification standards. The Director develops the quality strategy, builds organizational capability, leads regulatory and customer audits, and drives a culture in which quality, compliance, and continuous improvement are embedded in daily operations. Key ResponsibilitiesQuality Strategy and Leadership

• Develop, implement, and maintain the company's quality strategy, policies, objectives, and annual quality plan in alignment with business priorities and regulatory requirements.
• Lead, coach, and develop Quality Assurance, Quality Control, inspection, compliance, and other assigned quality teams; establish clear roles, decision rights, succession plans, and performance expectations.
• Serve as the senior quality advisor to executive leadership and provide objective, risk-based recommendations regarding product disposition, compliance, operational risk, and quality investments.
• Promote a culture of accountability, data integrity, product safety, right-first-time execution, and timely escalation of quality concerns. Quality Management System and Compliance
• Own and continuously improve the QMS, including document control, training, deviations, nonconformances, corrective and preventive actions (CAPA), change control, complaints, investigations, supplier quality, internal audits, management review, and quality risk management.
• Ensure compliance with applicable requirements, including 21 CFR Part 111, relevant provisions of 21 CFR Part 117 where applicable, company procedures, customer requirements, and recognized certification standards.
• Interpret current and emerging laws, regulations, guidance, and industry expectations; assess business impact and lead timely implementation of required changes.
• Ensure quality records are complete, accurate, contemporaneous, attributable, legible, traceable, and retained in accordance with approved procedures and applicable requirements. Product Quality and Release
• Establish and maintain specifications, sampling plans, inspection controls, test methods, acceptance criteria, and release procedures for raw materials, packaging components, in-process materials, and finished products.
• Provide independent Quality Unit oversight of material and product status, including approval, rejection, quarantine, rework, and final disposition decisions.
• Oversee batch production record review, laboratory and inspection activities, out-of-specification or atypical result investigations, and product quality trending.
• Partner with Operations, R&D, Engineering, Procurement, and Supply Chain to ensure quality requirements are incorporated into product development, process transfer, validation, scale-up, and commercialization. Audits, Inspections, and External Relationships
• Lead and host regulatory, certification, customer, and partner audits; coordinate inspection readiness, facility tours, document requests, responses, corrective actions, and commitments through closure.
• Develop and execute a risk-based internal audit program and ensure identified observations are investigated, remediated, and verified for effectiveness.
• Oversee supplier, contract manufacturer, laboratory, and service-provider qualification, monitoring, audits, quality agreements, and performance management.
• Maintain professional, credible relationships with regulators, certification bodies, customers, suppliers, and other external stakeholders. Investigations, Complaints, and Continuous Improvement
• Ensure deviations, complaints, nonconformances, recalls or market actions, and other quality events are investigated thoroughly, documented appropriately, and resolved within established timelines.
• Approve significant investigations, root-cause analyses, CAPAs, effectiveness checks, and formal responses to customers or external agencies.
• Define and monitor quality performance indicators such as complaint rate, right-first-time performance, deviation and CAPA aging, audit observations, supplier performance, release cycle time, and cost of poor quality.
• Use trend analysis, risk assessment, problem-solving methods, and cross-functional improvement initiatives to reduce recurring issues, strengthen process capability, and improve customer satisfaction. Department and Business Management
• Prepare and manage the Quality department budget, staffing plan, laboratory or inspection resources, external testing needs, and capital requirements.
• Establish departmental procedures, training plans, workload priorities, and operating rhythms that support timely product release and effective compliance oversight.
• Prepare executive updates, management review materials, technical presentations, quality reports, and regulatory or customer communications.
• Perform other duties consistent with the scope and level of the position. Decision Authority
• Authority to stop production, testing, packaging, release, shipment, or distribution when product quality, consumer safety, data integrity, or regulatory compliance may be at risk.
• Authority to approve or reject materials, components, processes, suppliers, quality records, and finished products within the company's established governance framework.
• Authority to escalate significant quality or compliance risks directly to executive leadership. Required Qualifications
• Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, Food Science, Pharmaceutical Science, or a related scientific or technical discipline; an advanced degree is preferred.
• Minimum of 12 years of progressive quality experience in dietary supplements, pharmaceuticals, food, medical devices, cosmetics, or another regulated manufacturing environment.
• Minimum of 7 years of people-leadership experience, including responsibility for managers or supervisors and multidisciplinary quality functions.
• Demonstrated expertise in cGMP regulations and quality systems, including investigations, CAPA, change control, complaints, supplier quality, audit management, label regulations, and product disposition.
• Demonstrated experience leading regulatory, certification, and customer audits and preparing effective written responses and remediation plans.
• Excellent written, verbal, presentation, negotiation, and cross-functional leadership skills. Preferred Qualifications
• Experience in dietary supplement manufacturing and direct working knowledge of 21 CFR Part 111.
• Professional certification such as ASQ Certified Manager of Quality/Organizational Excellence, Certified Quality Auditor, Certified Quality Engineer, or equivalent.
• Experience with electronic QMS platforms, laboratory information systems, ERP systems, statistical analysis, and quality data visualization.
• Experience with

NSF/ANSI

455-2, ISO-based systems, Kosher, Halal, organic, or other third-party certification programs, as applicable to company operations.

• Working knowledge of validation, stability programs, method suitability or verification, sanitation controls, food safety systems, and recall or crisis management. Leadership Competencies
• Sound judgment: evaluates complex information, regulatory risk, business constraints, and potential consequences before selecting a course of action.
• Executive presence: communicates clearly and credibly with employees, customers, auditors, regulators, suppliers, and senior leaders.
• Operational partnership: balances independent Quality Unit authority with pragmatic, collaborative support of manufacturing and business objectives.
• Accountability and execution: converts strategy into clear priorities, owners, timelines, and measurable results.
• Talent development: builds capable teams through coaching, feedback, delegation, and thoughtful succession planning.
• Continuous improvement mindset: identifies systemic opportunities and implements sustainable, data-driven solutions. Physical and Work Requirements
• Ability to perform primarily sedentary office work with periodic standing, walking, bending, and movement throughout manufacturing, warehouse, laboratory, and office environments.
• Ability to occasionally lift or move up to 20 pounds.
• Visual acuity sufficient to review detailed records, computer screens, labels, inspection results, and product or packaging attributes.
• Ability to wear required personal protective equipment and comply with facility hygiene, safety, and gowning requirements.
• Ability to travel periodically for supplier audits, customer meetings, training, or other business needs.

Acknowledgment This job description summarizes the primary duties and qualifications of the position. It is not intended to be an exhaustive list of all responsibilities. Duties may change based on business needs, regulatory requirements, and organizational priorities. Reasonable accommodations may be provided to qualified individuals with disabilities in accordance with applicable law.

Job Type:

Full-time Pay:

$80,000.00 - $120,000.00 per year

Benefits:

401(k) Dental insurance Employee discount Health insurance Life insurance Paid time off Retirement plan Vision insurance

Work Location:

In person