Sr. Director/Director Clinical Quality Assurance and Compliance

Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with excellent interpersonal, communication and professional skills. I am an analytical, logical planner and thinker. I have established favorable interactions with various investigators, vendors, colleagues (both internationally and locally), and clients. Handle highly confidential matter with discretion. I have encompassed procedures which would help ensure quality and integrity of the data obtained from clinical testing; to protect the rights and safety of clinical subjects to assure that any Agencies (FDA/EMEA/MHRA/TGA) decisions are based upon the data being concise and in compliance. Prepare quality documents by following applicable Agency regulations, ICH/GCP guidelines, Business Practices and procedures for New Drug Applications and Investigational New Drug submissions, as well as Biologics License Applications (BLA/sBLA).

Clinical Research