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With over 20 years of work experience in the pharmaceutical and biotechnology industries, I am a seasoned quality and compliance leader with a passion for cellular therapy and clinical research. My core competencies include quality management systems, compliance, regulatory defense, and quality auditing. I am currently looking for new opportunities to apply my skills and knowledge to support innovative and impactful projects in the field of biotechnology.In my most recent role as Senior Manager, Quality and Compliance at MMS, I managed and developed processes for the service line of Quality as a Service, providing QMS, compliance, and regulatory defense consultation services for pharmaceutical clients. I also performed audits and ensured adherence to ISO 13485, GCP, and other standards. I leveraged my skills in management review, quality management, and quality auditing to deliver high-quality and reliable services to clients. I also collaborated with cross-functional teams and stakeholders to ensure alignment and communication of quality objectives and expectations.
Darrow Quality Consulting
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Quality Assurance ConsultantDarrow Quality Consulting Jan 2024 - PresentTampa, Florida, United StatesProvide Quality Management System implementation for early stages of pharmaceutical. Create Quality Plans to assure inspection readiness at any point of clinical development.Third party auditor for GMP, GCP.
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Quality As A Service Line ManagerInternational Cro Jul 2022 - Dec 2023Manager of Quality as a Service. Manage and develop processes for the service line.Strategic planning for the service line.Provide QMS, Compliance, and Regulatory defense consultation services for pharmaceutical clients.Performed audits.
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Executive Management Of Quality DepartmentCryo-Cell Jul 2014 - Jul 2022Responsible for establishing and maintaining the Quality Management System and meeting all regulatory requirements for Cellular Therapy products, Clinical Research products, and Medical Devices.Responsible for ensuring quality aligned with the strategic planning and growth of the company.Implementation of ZenQMS.Regulatory Inspection readiness.Hosted regulatory and accreditation inspectionsManaged CMOs and testing laboratories -
Quality Assurance Director For Cellular TherapiesHoxworth Blood Center, University Of Cincinnati Mar 2007 - Jul 2014Responsible for all Quality systems and regulatory requirements for all Cellular Therapy products. Assisted in quality systems for the blood center. ETQ administrator; developed quality modules.
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Senior Qa AssociatePedimed Pharmaceutical 2006 - 2007• Maintained Quality oversight of Clinical Trial (phase 2) activities.• Performed audits of contract manufacturer and suppliers.• Established the company Quality Assurance systems. Used Access databases to create Document Control, Training, and Customer Complaints tracking.
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Qa AssociateAlkermes 2001 - 2005Ensure compliance to all quality SOPs. -
Research AssistantUniversity Of Cincinnati Oct 1999 - Oct 2000Managed lab and performed experiments. Oversaw grant budget. Supervised student workers.
Andrea Darrow Skills
Andrea Darrow Education Details
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Pharmaceutics And Drug Design -
Biotechnology
Frequently Asked Questions about Andrea Darrow
What company does Andrea Darrow work for?
Andrea Darrow works for Darrow Quality Consulting
What is Andrea Darrow's role at the current company?
Andrea Darrow's current role is Expert Quality Assurance and Compliance leader.
What is Andrea Darrow's email address?
Andrea Darrow's email address is ad****@****ell.com
What is Andrea Darrow's direct phone number?
Andrea Darrow's direct phone number is +151320*****
What schools did Andrea Darrow attend?
Andrea Darrow attended University Of Cincinnati, Rochester Institute Of Technology.
What are some of Andrea Darrow's interests?
Andrea Darrow has interest in Children, Environment, Education, Science And Technology, Health.
What skills is Andrea Darrow known for?
Andrea Darrow has skills like Quality Assurance, Gmp, Quality System, Capa, Change Control, Pharmaceutical Industry, Gxp, 21 Cfr Part 11, Quality Control, Validation, Fda, V&v.
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Andrea Darrow, RPA
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