Quality Systems Manager

The Coca-Cola Company•Cidra, PR

2d•Onsite

About The Position

The Quality Systems Manager – Integrated Management System (IMS) is a senior individual contributor responsible for directly planning, leading, and executing the CPSNA internal audit program. This role actively manages and coordinates compliance, governance, and assurance activities within the Integrated Management System and provides hands‑on support for quality assurance programs across all operational functions of CPSNA. The Quality Systems Manager works closely with operational teams to ensure effective implementation, monitoring, and continuous improvement of quality systems. The role evaluates the effectiveness, conformity, and implementation of the CPSNA’s IMS through risk‑based and process‑based internal audits, risk assessments, and compliance evaluations covering Quality, Food Safety, GMP, Environmental, and Occupational Health & Safety, as well as applicable organic certification requirements. Through these activities, the position identifies systemic risks and opportunities for continual improvement related to quality and food safety process performance, internal controls, and preventive capabilities. Where justified by risk or business need, the role may lead or co‑lead improvement initiatives and other assigned activities that support quality and food safety system effectiveness, Integrated Management System (IMS) objectives, or broader business priorities. In this capacity, the role engages, influences, and aligns stakeholders at all levels of the organization to drive effective outcomes. This role ensures ongoing compliance with The Coca‑Cola Operating Requirements (KORE), FDA and FSMA regulations, applicable ISO standards (ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000 / FSSC 22000), and USDA National Organic Program (NOP – 7 CFR Part 205), where applicable. The position applies ISO 19011 auditing principles and serves as a technical and compliance advisor to Quality & Food Safety Systems Leadership and the Plant Leadership Team, supporting risk‑based decision‑making and maintaining a continuous audit‑ready state.

Requirements

Bachelor’s degree in Science, Engineering, Food Technology, or related field.
10+ years in Quality, Food Safety, or Manufacturing (food, beverage, pharmaceutical).
Internal audit experience; Lead Auditor preferred.
English and Spanish (bilingual)
ISO 14000, ISO 18000, Microsoft Office, Six Sigma, Troubleshooting, Waterfall Model

Nice To Haves

ASQ CQA or equivalent
ISO 9001 / FSSC 22000 Lead Auditor
ISO 14001 / ISO 45001 Lead Auditor
FSMA PCQI

Responsibilities

Lead, plan, and directly execute the Plant Internal Audit Program in alignment with ISO 19011, KORE, corporate requirements, and internal procedures.
Develop, maintain, and adjust a documented, risk‑based and process‑based annual audit plan considering: Critical and high‑risk processes, Food safety, regulatory, and certification impact (including organic, where applicable), Historical audit results, nonconformances, and system performance trends, New or significantly changed processes, products, ingredients, or technologies, Updates to regulatory, KORE, corporate, or certification requirements.
Review audit results, KPIs, complaints, regulatory findings, and trends to identify systemic risks and continual improvement opportunities related to quality and food safety process effectiveness.
Ensure auditor competence, independence, objectivity, and ethical conduct in accordance with ISO 19011.
Plan and conduct internal audits covering Quality, Food Safety, GMP, Environmental, and Occupational Health & Safety requirements.
Assess effectiveness of policies, procedures, operational controls, and risk mitigation measures.
Ensure audits evaluate process performance and control effectiveness beyond documentation compliance.
Facilitate cross‑functional auditor participation while maintaining auditor independence.
Ensure Plant compliance with applicable FDA, FSMA, KORE, ISO, corporate, and USDA NOP requirements, where applicable.
Monitor, interpret, and communicate changes in regulations and standards impacting the IMS.
Conduct gap and impact assessments and coordinate implementation actions with responsible functions.
Coordinate and verify closure of Corporate Calls to Action (CTAs) and CPS requirements.
Ensure effective integration of USDA NOP (7 CFR Part 205) requirements into the Plant IMS.
Incorporate organic requirements into the internal audit program using a risk‑based, process‑based approach.
Coordinate and support external organic certification and surveillance audits.
Verify compliance related to approved raw materials, segregation, prevention of commingling, sanitation controls, traceability, mass balance, and record integrity.
Ensure organic‑related nonconformances are corrected and verified for effectiveness.
Ensure HACCP and Food Safety Plan documentation is current, accurate, and controlled per FSMA, ISO 22000, and FSSC 22000.
Lead HACCP reviews and reanalysis when required due to changes, incidents, complaints, or regulatory updates.
Lead the Plant Food Safety Team and ensure effective hazard analysis, decision‑making, and documentation.
Lead Food Fraud vulnerability assessments using recognized methodologies.
Define and verify risk‑based mitigation strategies and supplier integration.
Lead and maintain the Plant Food Defense Program in compliance with FSMA IA Rule and FSSC 22000.
Develop, reanalyze, and maintain the Food Defense Plan and mitigation controls.
Lead Food Safety Culture maturity assessments as required by FSSC 22000.
Support action plans to strengthen food safety culture and leadership behaviors.
Own the Plant Validation Program, ensuring risk‑based planning, compliance, and effectiveness.
Verify execution by responsible functions; accountability is for compliance, not execution.
Prepare accurate audit reports.
Ensure CAPAs address root causes and are effective.
Track and verify effectiveness of actions from internal, regulatory, certification, and organic audits.
Plan and evaluate traceability and mock recall exercises per FSMA, KORE, FSSC 22000, and USDA NOP.
Verify corrective actions for identified gaps.
Identify and assess risks impacting product safety, quality, regulatory compliance, or consumer protection.
Support containment and mitigation actions.
Exercise authority to stop production or shipment when product integrity is at risk.
Analyze audit, validation, traceability, complaint, and compliance data to identify trends and improvement opportunities related to quality and food safety process effectiveness.
Identify and recommend risk‑based improvement initiatives aligned with Quality 4.0, including data analytics, SPC, digital monitoring, and automation of verification activities.
Lead or co‑lead quality and food safety improvement projects when assigned, ensuring projects are well‑scoped, risk‑based, and aligned with ISO 9001, ISO 22000, FSSC 22000, KORE, and IMS objectives.
Ensure projects focus on system effectiveness and internal control strengthening and do not extend to general operational, engineering, environmental, or safety projects.
Provide objective, data‑driven insights to Plant Leadership using structured problem‑solving methodologies.
Serve as Plant contact for external audits and inspections.
Coordinate preparation, execution, and follow‑up for external audits and inspections.
Ensure audit, validation, and compliance records are controlled and retained.
Support training related to Quality, Food Safety, GMP, and compliance.
Communicate requirements effectively at all organizational levels.
Support IMS objectives, KPIs, and continual improvement.
Promote compliance with ISO 9001, ISO 22000 / FSSC 22000, ISO 14001, and ISO 45001.
Contribute to identification of IMS improvement opportunities through objective assessment of process performance and control effectiveness.
Maintain professional competencies and certifications.
Report incidents impacting safety, environment, quality, or food safety.
Promote risk‑based thinking and prevention of nonconformances.