Headquartered in the Bay Area and supporting projects nationwide, Quigley Compliance Associates is a Women’s Business Enterprise National Council (WBENC) certified small consulting firm servicing pharmaceutical, med device, and biotech clients on and between coasts. From inception to completion of a project, we specialize in compliance within the life science fields.
Our consultants are professionals who are well versed in regulatory specifications pertaining to the life sciences industry. We are a consulting firm that focuses on the whole lifecycle approach to compliance and validation, customizing the process for each individual client. Our specialty is collaborating with our clients on their projects while ensuring the small details don't go unnoticed.
Owner & CEO
Caitlin brings ten plus years of experience in project management, compliance, writing and executing protocols, drafting summary reports, and compiling test data into protocol data packages. She is well-versed in understanding, interpreting, and advising on regulations, guidelines, procedures, and policies related to development, research and manufacture of pharmaceutical, med device, and biotech products. Her meticulous approach leads to improved submission, review, and approval of global products and applications. Caitlin is a skilled project manager - having led multiple projects concurrently. Her experience includes identifying data and packages risks, and the formulation of new approaches. She is able to drill down to the smallest technical detail while remaining mindful of the big picture and bottom line.
Activities & Affiliations
• Member Board of Directors, My Green Labs
• Women In Bio, Programming Co-Chair
Kevin has over ten years as an experienced Senior Validation Engineer with a demonstrated history of working in the pharmaceuticals and military contracting fields. He is skilled in HVAC, Facilities, Utilities commissioning and validation and has experience with Corrective and Preventive Action (CAPA), Preventative Maintenance, Calibration and Change Control programs. Kevin is a strong quality assurance professional with a BBA focused in Business Administration from Temple University - Fox School of Business and Management.