The Quality Program Manager is responsible for ensuring the highest quality standards in production, manufacturing, inbound receiving, and chemical mixture processes. This role owns overall quality program strategy including: developing and implementing quality control systems, overseeing audit/inspection success, and ensuring compliance with industry regulations and company policies. The ideal candidate will have a strong background in manufacturing quality management, process improvement, and regulatory compliance. This is an individual contributor role that reports to the Operations Director.

Key Responsibilities:

• Develop, implement, and maintain quality control processes to ensure compliance with industry standards and company policies.
• Oversee and manage the quality assurance of all manufacturing processes, including inbound receiving, outbound shipping, production, and chemical mixture operations.
• Monitor and evaluate inbound raw materials and components to ensure they meet established quality specifications.
• Provide training and guidance on quality control procedures to all team members as necessary. Track completions in LMS.
• Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate risks.
• Conduct regular audits and inspections to assess compliance with quality standards, regulatory requirements, and safety protocols.
• Collaborate with cross-functional teams, including production, supply chain, and R&D, to improve quality and efficiency.
• Maintain and analyze quality data, generating reports to identify trends and areas for improvement.
• Ensure all quality documentation, including Standard Operating Procedures (SOPs) and work instructions, are up to date and properly followed.
• Manage customer complaints and non-conformance reports, working with stakeholders to drive resolutions.
• Stay updated on industry trends, new quality methodologies, and regulatory changes to enhance quality programs.
• Lead the company’s effort to achieve ISO 9001 certification by developing and implementing necessary quality systems and processes. Perform ISO audits as required.
• Lead the company’s effort to achieve GMP certification by ensuring all requirements are met prior to audits. Stays current to cGMP standards and FDA regulations and enforces a local program that stays in compliance.

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, Chemistry, or a related field.
• 5+ years of experience in a manufacturing quality management role.
• Strong knowledge of quality management systems (QMS), ISO 9001, and other relevant quality standards.
• Experience with chemical mixture quality control and regulatory requirements.
• Proficiency in root cause analysis and corrective action planning.
• Ability to earn trust in a position of influence while fostering a culture of continuous improvement.
• Strong analytical and problem-solving skills.
• Excellent communication skills with the ability to work collaboratively across departments.
• Experience with quality auditing and supplier quality management.