Compliance Officer

About the Role:

The Compliance Officer is responsible for providing independent oversight of regulatory compliance, quality systems, and operational excellence across multiple manufacturing facilities. This role ensures adherence to FDA regulations, Current Good Manufacturing Practices (cGMP), food safety standards, and internal quality systems while supporting audit readiness and continuous improvement initiatives. The ideal candidate has experience in compliance, quality assurance, regulatory affairs, and manufacturing operations within a regulated industry, with a passion for driving a culture of accountability, risk management, and operational excellence.

Responsibilities:

• Conduct routine internal audits of manufacturing operations, documentation, sanitation programs, quality systems, and Current Good Manufacturing Practice (cGMP) compliance.
• Ensure compliance with FDA regulations, including 21 CFR Part 111 and Part 117, Food Safety Modernization Act (FSMA) requirements, internal policies, and customer quality standards.
• Monitor day-to-day manufacturing operations to verify compliance with regulatory requirements, quality standards, and established operating procedures.
• Prepare manufacturing facilities for customer, regulatory, certification, and third-party audits by assessing readiness and addressing compliance gaps.
• Support regulatory inspections and customer audits by coordinating documentation, facilitating audit activities, and assisting with corrective actions.
• Investigate compliance issues, deviations, nonconformances, customer complaints, and quality events using structured root cause analysis methodologies.
• Manage, track, and verify the implementation and effectiveness of Corrective and Preventive Actions (CAPAs) to ensure timely resolution and continuous improvement.
• Review standard operating procedures (SOPs), batch production records, manufacturing documentation, quality records, and controlled documents for accuracy and regulatory compliance.
• Perform routine facility inspections and operational walkthroughs to proactively identify compliance risks and recommend preventive solutions.
• Partner with Quality Assurance, Production, Research and Development, Maintenance, Warehouse, Environmental Health and Safety, Human Resources, and Operations teams to strengthen compliance programs.
• Assist in developing and delivering GMP, regulatory compliance, quality systems, and operational training programs for employees.
• Monitor changes in regulatory requirements and industry standards while recommending updates to internal procedures, policies, and compliance programs.
• Promote a culture of quality, regulatory compliance, accountability, continuous improvement, and operational excellence throughout the organization.

Qualifications:

• Bachelor's degree in Quality Assurance, Food Science, Biology, Chemistry, Manufacturing, Regulatory Affairs, Life Sciences, Engineering, or a related field, or equivalent professional experience.
• Minimum of three years of experience in compliance, quality assurance, regulatory affairs, or quality systems within a manufacturing environment.
• Experience in dietary supplements, nutraceuticals, pharmaceuticals, food manufacturing, medical devices, consumer packaged goods, or another FDA-regulated industry.
• Strong knowledge of FDA regulations, Current Good Manufacturing Practices (cGMP), Food Safety Modernization Act (FSMA), quality management systems, and regulatory compliance requirements.
• Experience conducting internal audits, supplier audits, regulatory inspections, and compliance assessments.
• Demonstrated experience managing Corrective and Preventive Action (CAPA) programs, deviation investigations, root cause analysis, and continuous improvement initiatives.
• Strong understanding of quality documentation, document control, SOP management, batch records, change control, and regulatory recordkeeping.
• Excellent analytical, organizational, problem-solving, and risk assessment skills with exceptional attention to detail.
• Strong written and verbal communication skills with the ability to collaborate effectively across cross-functional teams and all levels of the organization.
• High level of integrity, professionalism, accountability, and the ability to manage multiple priorities in a fast-paced manufacturing environment.
• Ability to travel between multiple manufacturing facilities as needed.

Desired Qualifications:

• Professional certifications such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), HACCP, Preventive Controls Qualified Individual (PCQI), Lean Six Sigma Green Belt or Black Belt, or related quality certifications.
• Experience preparing manufacturing facilities for FDA, customer, certification body, and third-party regulatory audits.
• Knowledge of ISO quality management systems, supplier quality management, risk management methodologies, and quality assurance best practices.
• Experience implementing continuous improvement initiatives using Lean Manufacturing, Six Sigma, Kaizen, or operational excellence methodologies.
• Familiarity with electronic quality management systems (eQMS), document management systems, audit management software, and compliance tracking tools.
• Demonstrated ability to lead cross-functional compliance initiatives that improve product quality, regulatory readiness, operational efficiency, and long-term organizational performance.