Job Description

Position Title:  Senior Compliance Analyst 

Reporting to:  Director, Regulatory Affairs, Quality and Compliance Services 

Position Summary:

The Senior Compliance Analyst is a technical position that reports to the Director, Regulatory Affairs, Quality and Compliance Services.

The Senior Compliance Analyst is responsible for understanding compliance with government regulations with special attention to a Quality System that meets global regulatory expectations and enables CLIENTS to effectively work with vendors who are qualified and capable of supporting the 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 appropriate 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 should also be able to review CLIENTS business practices and prepare SOPs to implement a required quality system. Attention to detail is expected to ensure high quality documents. 

The position requires a high level of integrity as this person is representing the CLIENT to a number of external organizations and the Regulatory agencies (FDA, EMEA) as needed, and actions impact the quality and reliability of our products.

Key Responsibilities:

• Create, review, and revise Quality System documents, such as Quality Manual, SOPs, and Quality Agreements.
• Compile training files for CLIENT employees and consultants.
• Provide training on SOPs.
• Perform audits of Third Party Organizations for GMP, GLP, and/or GCP. Submit report to audited party and CLIENT.
• Prepare regulatory submission documentation.
• Review documentation for accuracy and completeness

Qualifications required:

• 5 years experience in a Regulatory/Quality Compliance field.
• Bachelor’s degree in scientific field. Other advanced degree in science (MS or PhD) would be helpful.
• Strong problem solving and communication skillsBroad knowledge of Quality systems and working knowledge of how to effectively manage quality.
• Knowledge of the Global Regulatory approval processes and requirements.
• Excellent project management skills.
• Strong interpersonal skillsHigh sense of integrity.
• Entrepreneurial spirit