Compliance and Risk Manager
6 days ago
We are seeking a skilled Compliance and Risk Manager to join our quality assurance team and support the development and implementation of quality assurance strategies and programs.
This role will involve leading the management of risks and ensuring compliance with regulatory requirements.
About Us: At Eli Lilly and Company, we're dedicated to discovering and delivering innovative solutions that improve human health and transform lives.
Key Responsibilities:
- Quality Assurance Oversight:
- Develop and implement quality assurance strategies and programs, aligned with regulatory requirements.
- Oversee Commissioning and Qualification (C&Q) activities, ensuring quality and integrity.
- Investigate and resolve deviations, non-conformities, and CAPA.
- Regulatory Compliance:
- Monitor and stay up-to-date with changing regulations and guidelines.
- Support regulatory inspections and audits, ensuring compliance with regulatory requirements.
- Verify that all products meet regulatory standards.
- Documentation and Reporting:
- Maintain accurate and comprehensive quality records, including procedures, qualifications, and quality reports.
- Prepare and review documentation related to product quality and compliance.
- Quality Improvement Initiatives:
- Promote continuous improvement by identifying areas for process enhancement and collaborating with cross-functional teams.
- Participate in risk assessments and quality improvement projects.
- Training and Development:
- Train staff on quality-related procedures and best practices.
- Stay current with the latest developments in biotechnology and quality assurance.
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