Quality and Regulatory Affairs Manager.

A Quality and Regulatory Affairs Manager oversees an organization's quality assurance and ensures compliance with all relevant regulations, policies, and standards. Key responsibilities include developing and implementing quality management systems, managing audits and inspections. This role often involves leading a team, reporting on quality metrics to management, and ensuring products and processes consistently meet quality and regulatory requirements.

Key responsibilities

Manage the quality management system (QMS) as a whole and support process owners in managing their processes

·       Identify regulatory requirements in collaboration with Regulatory affairs, perform gap analyses and coordinate the implementation.

·       Plan and evaluate changes in collaboration with process owners and follow-up on their implementation.

·       Maintain the quality policy, quality objectives, and quality manual including process overview, key performance indicators.

·       Support the process owners to implement the policy, regulatory requirements, standards and guidance, and review procedures for conformance.

·       Communicate the quality policy, quality objectives and quality effectiveness to the organization.

·       Organize and perform internal audits and manage external audits and inspections.

·       Review complaint and nonconformity reports including CAPA activities.

·       Manage regulatory submissions, registrations and notifications.

 Experience& Qualification.

·       A successfully completed degree, preferably in food science or related field. Advanced degrees are highly desirable.

·        At least 5 years experience in QA/RA in food industry or over 3 years hands-on experience with quality management system (QMS).

·       Good understanding of ISO, FDA, GMP, HACCP and EU regulations.

·       Cross-functional, risk-based and innovative thinking skills.

·       Accurate and punctual attitude.

·       Good presentation and communication skills.

·       Good knowledge of English (written and spoken)

·       Team-player.

·   Able to work Monday through Saturday.

·  Applicants with experience in coordinating with external agencies such as the Department of Fisheries, the Department of Livestock Development, and the Food and Drug Administration (FDA) will be given special consideration.