Compliance Manager-Biopharma

Job OverviewWe 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.ResponsibilitiesDevelop, 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.SkillsStrong 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.

Created: 2025-02-23