DONALD BATES
Quality Professional with Global Experience
DONALD BATES
Quality Professional with Global Experience
Quality Professional with Global Experience
Quality Professional with Global Experience
30+ years of global experience in leading GMP compliance, regulatory inspection management, risk mitigation, and strategic business alignment. Implemented global inspection readiness strategies across affiliates and CMOs. Experience with global regulatory agencies including FDA (USA), EMA (EU), MHRA (UK), HC (Canada), PMDA (Japan), ANVISA (Brazil), HSA (Singapore), and SFDA (Kingdom Saudi Arabia). Ensure 500+ worldwide GXP vendors adhere to regulations by managing 175+ annual audits driving continuous compliance. Personally recognized by Amgen CEO for promoting a sense of community and mentoring through volunteering in an employee support group.
Principal of a full-service GMP readiness and compliance consulting firm for over 20 years. Specialized in inspection readiness, risk management, vendor oversight, quality systems, and regulatory submissions for the following:
The following summarizes key consulting services delivered.