Job Description

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

Pay: 35,000.00-40,000.00 per year

Benefits:

Employee discount On-site parking
Experience:

Compliance management: 2 years (required)
Work Location: In person