Senior Compliance Analyst
Position Title: Senior Compliance Analyst
Reporting to: Director, Regulatory and Compliance Services
Position Summary: The Senior Compliance Analyst is a technical position that reports to the Director Regulatory and Compliance Services.
The Senior Compliance Analyst is responsible for understanding compliance with government regulations with special attention to Quality Systems that meet global regulatory expectations and enables clients to effectively work with vendors who are qualified and capable of supporting clinical and commercial activities. The Senior Compliance Analyst will collaborate with internal staff in development of improved capabilities in the areas of documentation, coding and compliance, will assist in performing analysis of current situations and recommend priorities and goals for future company needs, review internal controls, policies and procedures to ensure compliance with applicable State and Federal guidelines and policies, and will respond promptly to external and internal concerns; implementing corrective actions as appropriate.
The Senior Compliance Analyst will be familiar with Health Authority expectations for regulatory submissions and may assist in preparation of such submissions. The Senior Compliance Analyst will review client’s business practices and prepare SOPs to implement a required quality system. Attention to detail is expected to ensure high quality documents.
This position requires a high level of integrity as this person is representing the client to a number of external organizations and regulatory agencies (FDA, EMEA) as needed. The actions of the Senior compliance Analyst will have an impact on the quality and reliability of the client’s products.
- Create, review, and revise Quality System documents, such as Quality Manuals, SOPs, and Quality Agreements
- Compile training files for client employees and consultants
- Provide training on SOPs
- Perform audits of Third Party Organizations for cGMP, cGLP, and/or cGCP
- Submit report to audited party and client
- Prepare and review regulatory submission documentation
- Review documentation for accuracy and completeness
- 5 years of experience in the Regulatory and/or Quality Compliance fields
- Bachelor’s degree in a scientific field
- Other advanced degree in science (MS or PhD) would be helpful
- Strong problem-solving and communication skills
- Broad knowledge of Quality systems
- Working knowledge of how to effectively manage quality
- Knowledge of the Global Regulatory approval processes and requirements
- Excellent project management skills
- Strong interpersonal skills
- High sense of integrity
- Entrepreneurial spirit