Quality Systems Manager

The Manager, Quality Systems is responsible for the development, implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS) to ensure compliance with applicable FDA requirements, 21 CFR Parts 210 and 211, ISO 22716, customer requirements, and company procedures. This position provides leadership and oversight for key quality system processes, including CAPA, nonconformance, change control, SOP/document management, training, internal audits, external audits, supplier audits, and audit commitments.

The Manager ensures quality system issues are appropriately investigated, documented, resolved within established timelines, and evaluated for effectiveness. The Manager also leads and develops Quality Systems personnel, establishes performance expectations, monitors QMS KPIs and trends, and promotes a proactive quality culture across the organization.

• Manage and maintain the QMS, ensuring systems remain current, effective, compliant, and aligned with business and regulatory requirements.
• Oversee QMS processes (CAPA, Nonconformance, Deviation, Change Control, SOP/Document Control, and Training programs, etc.) ensuring systems follow applicable Regulatory and Standards and are streamlined for use.
• Manage the internal audit program and coordinate Customer, Regulatory, Certification, and Supplier audits.
• Oversee internal, external, and supplier audit schedule and performance to schedule.
• Lead audit preparation and maintain a continuous state of audit and inspection readiness.
• Oversee audit findings, commitments, and corrective actions through completion, including verification of effectiveness.
• Monitor QMS KPIs, trends, aging, and recurring issues; escape significant risks and drive appropriate corrective action.
• Ensure QMS processes are risk-based, consistently applied, and continuously improved.
• Lead and develop Quality Systems staff, including workload management, performance management, coaching, and training.
• Partner with cross-functional departments to ensure quality system requirements are understood, implemented, streamlined for use, and sustained.
• Support management review and provide QMS performance updates, trends, and recommendations for Operations and Quality/Regulatory leadership.
• Perform other duties as assigned by direct manager.

• Strong leadership and staff development capabilities.
• Ability to communicate effectively with internal teams, suppliers, and customers.
• Ability to work efficiently in a fast-paced environment with shifting priorities.
• Strong attention to detail, documentation accuracy, and time management skills.
• Knowledge of OTC & Cosmetic product manufacturing and testing processes or similar regulated industries.
• Ability to follow and enforce regulatory and procedural requirements.

• Bachelor’s degree in quality, Life Sciences, Engineering, or related field.
• 7+ years of experience in Quality Assurance/Quality Systems within a regulated manufacturing environment.
• Management or supervisory experience required.
• CQE, CQM, Six Sigma, and/or any type of Lean manufacturing certifications are strongly desired
• Strong working knowledge of FDA 21 CFR Parts 210/211 and ISO 22716.
• Strong experience managing and overseeing Quality Management Systems in a regulated manufacturing site.
• Strong leadership, organizational, analytical, communication, and problem-solving skills.

• Ability to lift and pull a minimum of 40 pounds using proper lifting techniques.
• Requires extended periods of standing, walking, and sitting.
• Requires bending, pulling, pushing, and reaching above shoulder and below waist levels.
• Use of personal protective equipment (PPE) required in designated areas.

• Work is performed in production, laboratory, and office environments.
• Exposure to varying noise levels, chemicals, and temperature fluctuations may occur.
• Must follow all safety, quality, and regulatory compliance procedures.

Supervises and directs QA Inspectors and Compliance Unit staff. Evaluates staff performance and recommends disciplinary…