Quality Program Manager

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.