Job Description

Position Title:  Compliance Advisor

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

Position Summary:

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

The Compliance Advisor will demonstrate in-depth knowledge and understanding compliance in a given Regulatory area and of selected contributing areas. The Senior Compliance Advisor is responsible for understanding compliance with government regulations with special attention to a GLP, GCP and/or cGMP Quality System that meets global regulatory expectations and enables CLIENTS to effectively work with vendors who are qualified and capable of conducting valid GLP studies, or conducting appropriate clinical research studies in compliance with GCP, and/or producing active pharmaceutical ingredients (API), formulating the drug product (DP), labeling & packaging the final drug product (FDP), warehousing intermediates, packaging materials and final products needed to support the clinical and commercial activities.

The Compliance Advisor will collaborate with internal staff in setting the strategic regulatory direction for products in different stages of development; in the 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 CLIENT 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 Compliance Advisor will demonstrate understanding of the cross-functional perspective of product development and post marketing support. The Compliance Advisor may serve as the primary contact for a CLIENT. The Compliance Advisor will develop regulatory strategies and ensure alignment with CLIENT development staff. At the request of the CLIENT, will effectively negotiate with regulators and regulatory agencies on drug/diagnostic/device development issues.

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 CLIENT’s 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.
• Develops and presents regulatory strategies for drug/device/diagnostic development to CLIENT management team or the Board of Directors.
• Presents differing viewpoints in a positive, constructive manner to the CLIENT.
• Clearly presents complex regulatory issues and the overall regulatory plans to CLIENT management.
• Represent Safis and its values in a professional manner at external meetings.

Qualifications required:

• 5 to 10 years years of experience in the Regulatory and/or Quality Compliance fields leading projects and directing strategy.
• Bachelor’s degree in scientific field. Other advanced degree in science (MS or PhD) would be helpful.
• Strong problem solving and communication skills.
• Broad knowledge of Quality systems and working knowledge of how to effectively manage quality at CMOs for the delivery of pharmaceutical products.
• Knowledge of the Global Regulatory approval processes and requirements Demonstrated experience in the Regulatory/Compliance field.
• Excellent project management skills.
• Strong interpersonal skills.
• High sense of integrity.
• Entrepreneurial spirit