Position Title: Quality Advisor
Reporting to: Director, Regulatory and Compliance Services
Position Summary: The Quality Advisor is a technical position that reports to the Manager, Regulatory and Compliance Services.
The Quality Advisor will demonstrate in-depth knowledge and understanding of compliance in a given Regulatory area and of selected contributing areas. The Quality Advisor is responsible for understanding compliance for government regulations with special attention to cGLP, cGCP and/or cGMP Quality Systems that meet global regulatory expectations and enables clients to effectively work with vendors who are qualified and capable of conducting valid cGLP studies, or conducting appropriate clinical research studies in compliance with cGCP, and/or producing active pharmaceutical ingredients (API), formulating the drug product (DP), labeling and packaging the final drug product (FDP), warehousing intermediates, packaging materials and final products needed to support clinical and commercial activities.
The Quality 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 applicable State and Federal guidelines and policies, and will respond promptly to external and internal concerns; implementing corrective actions as appropriate.
The Quality Advisor will demonstrate understanding of the cross-functional perspective of product development and post marketing support. The Quality Advisor may serve as the primary contact for the client. The Quality Advisor will develop regulatory strategies and ensure alignment with client development staff. The Quality Advisor, 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 regulatory agencies (FDA, EMEA) as needed. The actions of the Quality Advisor 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
Develop and present regulatory strategies for drug/device/diagnostic development for the client management team or the Board of Directors
Present differing viewpoints in a positive, constructive manner to the client
Clearly present complex regulatory issues and the overall regulatory plans to client management
- Represent Safis and its values in a professional manner at external meetings
- 5 + years of experience in the Regulatory and/or Quality Compliance fields leading projects and directing strategies
- 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
- 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 Regulatory/Compliance fields
- Excellent project management skills
- Strong interpersonal skills
- High sense of integrity
- Entrepreneurial spirit