Carolyne Mabwa

• Highly experienced QA Manager with 17+ years in manufacturing environments, including food, biotech, and industrial production.
• Expertise in GMP and Integrated Management Systems (IMS), CAPA, deviation handling, supplier qualification, regulatory compliance, and documentation control.
• Proven leadership in audit readiness, risk management, product release, and continuous improvement programs.
• Strong cross-functional collaborator with excellent problem-solving, communication, and decision-making skills.

• Lead IMS-aligned systems across production and laboratory operations.
• Oversee batch release, stability testing, traceability, and documentation approval.
• Manage CAPA, deviations, OOS investigations, and supplier quality programs.
• Conduct internal audits and prepare for regulatory inspections.
• Supervise QA staff, assign tasks, and promote a culture of quality.
• Implemented ISO 9001 and HACCP-compliant IMS.
• Managed product inspections, deviations, CAPA systems, and supplier audits.
• Approved COAs, MSDSs, and material specifications.
• Led QA team training, performance evaluation, and new product validation support.
• Oversaw IMS and GMP compliance across food and production operations.
• Managed supplier audits, ingredient compliance, traceability, and recalls.
• Supervised hygiene, sanitation, and warehouse QA systems.
• Led internal audits and employee training on QA standards.
• Managed ISO 9001, ISO 22000, GMP, and HACCP within an IMS framework.
• Oversaw batch release, allergen management, and sanitation validation.
• Controlled raw material, packaging, and finished product approvals.
• Investigated customer complaints and executed CAPA.
• Supported new product development and scale-up validation.
• Supervised laboratory operations and analytical testing.
• Controlled raw material, packaging, WIP, and finished product inspections.
• Ensured GMP compliance, hygiene audits, and documentation control.
• Investigated deviations and implemented corrective actions.

Implemented and sustained a fully integrated Quality, Risk, and Compliance Management System (IMS) aligned with ISO 9001, ISO 22000, GMP, and HACCP, achieving a 100% audit certification success rate.

Led 20+ regulatory, customer, and certification audits with zero major non-conformities, strengthening corporate compliance and governance.

Established enterprise-wide risk management frameworks and risk registers, reducing critical operational and product safety risks by 60%+.

Improved batch release turnaround time by 35% while strengthening allergen control, sanitation validation, and documentation integrity.

Reduced quality incidents (deviations, OOS, non-conformities, and customer complaints) by 50%+ through advanced CAPA, root-cause analysis, and preventive risk controls.

Directed 30+ supplier quality and compliance audits, raising supplier compliance from 70% to over 95%, and strengthening traceability and recall readiness with 100% trace-back success within 2 hours.

Led 100% approval control for raw materials, packaging, WIP, and finished products, eliminating material-related production shutdowns and compliance breaches.

Built and led a cross-functional QA, Risk, and Compliance team of 10–15 staff, improving staff performance and compliance adherence by 40% via targeted training and competency programs.

Strengthened GMP, hygiene, sanitation, and warehouse compliance, improving inspection readiness scores by 45% and significantly reducing contamination and regulatory risks.

Delivered 10+ fully compliant new product launches, ensuring complete risk assessment (HACCP, FMEA), validation, and regulatory approval.

Drove a company-wide risk-aware culture through continuous training, achieving 90%+ QA and compliance adherence across departments.