Compliance Manager
- Scunthorpe, Lincolnshire
- Permanent
- Full-time
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.
- 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.
- Employee discount
- On-site parking
- Compliance management: 2 years (required)