Angela K Dunston (Jw), MBA, Asq Cqa, Asq Cmq/Oe, Asq Cpgp
About Angela K Dunston (Jw), MBA, Asq Cqa, Asq Cmq/Oe, Asq Cpgp
Angela K Dunston is the Director of Quality Services at Azzur Group, where she has worked since 2021. She possesses extensive experience in quality management and regulatory compliance across various pharmaceutical and biotechnology sectors.
Work at Azzur Group
Angela K Dunston serves as the Director of Quality Services at Azzur Group since 2021. In this role, she applies her extensive knowledge of global Good Practice (GxP) regulations to develop innovative applications and custom services that incorporate risk management principles. Her leadership in quality services has contributed to the organization's commitment to compliance and operational excellence.
Previous Experience in Quality Management
Prior to her current position, Angela held several roles in quality management. She worked at Novartis as Associate Director of Global Quality Systems-QMS for 11 months in 2020-2021. Before that, she was a Quality Compliance Supervisor at Medicago for one year in 2018-2019. Additionally, she served as a Quality Assurance Manager at BioDelivery Sciences International for 7 months in 2020 and as Senior Supervisor of Quality Assurance at Nektar Therapeutics from 2007 to 2009.
Education and Expertise
Angela has a diverse educational background. She earned an MBA in Management from Strayer University (DC) and an Executive Graduate Certificate in Public Accounting from Strayer University-Alabama. She also holds a Bachelor's degree in Health Science from Campbell University and an Associate's degree in Industrial Pharmaceutical Technology from Wake Technical Community College. Angela has achieved multiple certifications from the American Society for Quality, including Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, and Certified Pharmaceutical GMP Professional.
Achievements in Quality Compliance
Angela has developed and implemented an organization-wide Data Integrity program that enhanced consistency, compliance, and operational effectiveness. She has led comprehensive audits for internal processes and external suppliers, utilizing root cause analysis to address non-compliance issues. Her expertise includes managing deviation protocols, CAPA processes, global supplier quality management, and handling complaints and change control.
Regulatory Knowledge and Specializations
Angela possesses extensive knowledge of regulations from the FDA, ICH, Health Canada, EMA, and ISO. She specializes in various areas of quality management, including deviation management, protocol deviations, and complaints handling. Her experience encompasses a wide range of dosage forms, such as oral, inhalation, parenteral, active pharmaceutical ingredients (API), cosmetics, excipients, vaccines, and gene therapy.