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Overview
We are seeking a detail-oriented and experienced Compliance Manager to oversee and ensure adherence to regulatory standards within our organisation. The ideal candidate will play a critical role in maintaining compliance with FDA regulations, managing quality assurance processes, and supporting clinical trials. This position requires a strong background in manufacturing controls and project management to effectively navigate the complexities of compliance in a dynamic environment.
Responsibilities
* Develop, implement, and maintain compliance programs that align with FDA regulations and industry standards.
* Monitor and evaluate compliance with internal policies and external regulations throughout the organisation.
* Lead investigations into compliance issues and recommend corrective actions as necessary.
* Collaborate with cross-functional teams to ensure that all aspects of clinical trials meet regulatory requirements.
* Conduct regular audits and assessments to identify areas for improvement in compliance management practices.
* Prepare and submit required documentation for regulatory submissions related to manufacturing processes.
* Provide training and guidance to staff on compliance-related topics to foster a culture of accountability.
* Stay updated on changes in regulations affecting the industry and communicate relevant updates to stakeholders.
Skills
* Strong knowledge of chemistry, manufacturing & controls principles.
* In-depth understanding of FDA regulations governing clinical trials and product development.
* Proven experience in compliance management within a regulated environment.
* Excellent project management skills with the ability to handle multiple projects simultaneously.
* Strong research skills to analyze complex regulatory information effectively.
* Proficient in quality assurance practices to ensure product integrity and safety.
* Exceptional communication skills, both written and verbal, to convey compliance requirements clearly across all levels of the organization.
Join our team as a Compliance Manager where your expertise will contribute significantly to our commitment to excellence in regulatory adherence and product quality.
Job Type: Full-time, Monday – Friday, 9am – 5pm
Benefits:
* Employee discount
* On-site parking
Experience:
* Compliance management: 2 years (required)
Work Location: In person
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