Job Overview

We are seeking a dedicated and detail-oriented Compliance Manager to oversee and ensure adherence to regulatory standards within our organization. The ideal candidate will possess a strong background in quality management and compliance, with a focus on FDA regulations, CGMP, and various quality systems. This role is critical in maintaining the integrity of our operations and ensuring that all processes meet industry standards.

Responsibilities

• Develop, implement, and maintain compliance programs that align with regulatory requirements.
• Conduct quality audits to assess adherence to internal policies and external regulations.
• Monitor compliance with FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• Collaborate with cross-functional teams to ensure effective quality management practices are in place.
• Lead training initiatives to educate staff on compliance protocols and quality assurance measures.
• Manage documentation related to quality systems and compliance activities.
• Identify areas for improvement within the compliance framework and propose actionable solutions.
• Prepare reports on compliance status and present findings to senior management.

Skills

• Strong understanding of quality audits and quality management principles.
• In-depth knowledge of FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• Proven experience in project management with the ability to lead initiatives effectively.
• Excellent analytical skills with attention to detail for identifying compliance issues.
• Strong communication skills for effective collaboration across departments.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Proficiency in developing quality systems that support organizational goals.

This Compliance Manager position offers an exciting opportunity for professionals looking to make a significant impact in ensuring regulatory adherence within our organization.