Job Description
* Develop and maintain quality systems to ensure compliance with current legislation, industry standards, and customer requirements.
* Support the Quality Management System (QMS) in achieving continuous improvement and excellence.
* Lead the operational performance of quality systems and drive the successful delivery of business objectives.
* Monitor and report on quality key performance indicators (KPIs) and coordinate regular review processes.
* Manage audit readiness, host regulatory, customer, and certification audits, and ensure inspection readiness.
* Oversee supplier and raw material approval protocols, ensuring compliance with specifications before purchase.
* Manage incoming material inspection and release, facilitate change control and deviation record reviews, and improve product recall processes.
* Lead the CAPA program, implementing corrective and preventive measures for noted deviations.
* Develop and implement the Annual Business Quality Review program and lead the customer complaints management process.
* Manage supplier non-conformances, communicate quality activities to stakeholders, and ensure quality assurance activities support routine production needs.
* Complete validation and qualification activities, provide expert guidance, and manage internal audits.
* Review and approve batch documents and quality control/microbiological data to support batch release.
* Support IT Quality System selection and lead implementation planning.
Requirements:
* Bachelor's degree in a technical discipline (Science, Quality, or Engineering).
* Master's degree preferred.
* 10+ years of experience in a quality leadership role, with 5+ years in process-based manufacturing for the food and/or pharmaceutical industry.
* Proven track record in developing and implementing successful quality systems and procedures.
* Strong general leadership and quality management experience, including quality execution, analysis, and deadline-driven work.
* Excellent computer skills, experience with MS Office, ERP systems, and IT Quality system software.
* Ability to effectively communicate with various stakeholders, including customers, cross-functional teams, and executive management.
* Strong self-motivation, ability to work independently and within a team, with excellent follow-up, organization, and prioritization skills, and attention to detail.
* Working knowledge of ISO 9001, FSSC 22000, and HACCP standards.