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.
