Quality Manager

Kalon Executive Search; United States; On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

401K match

Full benefits

Bonus

Job summary

Kalon Executive Search is seeking a Quality Manager to oversee daily quality operations within a regulated manufacturing environment. This role involves ensuring compliance with FDA regulations, fostering continuous improvement initiatives, and collaborating with cross-functional teams to uphold product quality and safety standards. Ideal candidates will have at least 5 years of leadership experience in related fields and a strong understanding of cGMP regulations. Compensation ranges from $100,000 to $110,000 per year, with full benefits and a bonus.

Qualifications

• Minimum 5 years of leadership experience in a regulated manufacturing environment.
• Strong knowledge of cGMP regulations and quality management systems.
• Experience with quality documentation platforms.

Responsibilities

• Lead and manage Quality Control operations and workflow.
• Ensure compliance with FDA regulations and Good Manufacturing Practices.
• Investigate quality events and implement corrective actions.

Skills

Leadership in quality operations

Knowledge of cGMP regulations

Organizational skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in a scientific or technical discipline

Tools

ERP systems

Microsoft Office suite

Job description

Quality Manager

The Quality Manager will oversee daily quality operations and provide leadership to the Quality Control function within a regulated manufacturing environment. This role is responsible for maintaining compliance with applicable regulatory standards, supporting laboratory and production quality activities, and driving continuous improvement initiatives across the organization. The Quality Manager will work cross‑functionally with production, supply chain, and customer partners to ensure product quality, safety, and compliance standards are consistently achieved.

Key Responsibilities

• Lead and manage Quality Control operations, including workflow coordination, scheduling, and team oversight.
• Develop, implement, and maintain quality systems, procedures, and reporting metrics.
• Ensure compliance with current Good Manufacturing Practices (cGMP), including applicable FDA regulations such as 21 CFR Part 111 and Part 117.
• Oversee raw material review, analytical testing programs, and product evaluation processes.
• Maintain material and product traceability throughout receiving, production, and distribution activities.
• Support laboratory operations, including sample management, testing workflows, documentation, and SOP adherence.
• Coordinate with customers, vendors, and third‑party laboratories to provide quality‑related documentation, including Certificates of Analysis (COAs), microbiological results, and compliance declarations.
• Assist with shelf‑life and stability program activities.
• Deliver training related to quality systems, cGMP standards, SOPs, and compliance expectations.
• Foster a continuous audit‑ready environment across quality and manufacturing operations.
• Manage retention sample inventory and associated documentation.
• Investigate quality events, non‑conformances, and production issues; implement corrective and preventive actions (CAPA) as needed.
• Collaborate closely with manufacturing teams to proactively identify and resolve quality concerns.
• Support internal audits and participate in preparation for customer, regulatory, and third‑party audits.
• Monitor manufacturing activities throughout all stages of production and authorize product release in accordance with established quality standards.
• Adapt quickly to changing priorities while providing operational support and backup leadership for quality personnel.

Qualifications & Experience

• Minimum 5 years of leadership experience within a regulated manufacturing environment such as dietary supplements, pharmaceuticals, food manufacturing, or related industries.
• Strong knowledge of cGMP regulations and quality management systems.
• Experience with ERP systems and quality documentation platforms.
• Advanced proficiency in Microsoft Office suite.
• Excellent organizational, communication, and problem‑solving skills.
• Ability to work independently and manage multiple priorities in a fast‑paced environment.
• Bachelor’s degree in a scientific or technical discipline preferred.

Compensation

$100,000-110,000 per year plus a bonus, full benefits, 401K match.

Kalon Executive Search is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.