Andrea Darrow

Andrea Darrow Email and Phone Number

Expert Quality Assurance and Compliance leader @
Andrea Darrow's Location
Greater Tampa Bay Area, United States
Andrea Darrow's Contact Details
About Andrea Darrow

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.

Andrea Darrow's Current Company Details
Darrow Quality Consulting

Darrow Quality Consulting

Expert Quality Assurance and Compliance leader
Andrea Darrow Work Experience Details
  • Darrow Quality Consulting
    Quality Assurance Consultant
    Darrow Quality Consulting Jan 2024 - Present
    Tampa, Florida, United States
    Provide 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.
  • International Cro
    Quality As A Service Line Manager
    International Cro Jul 2022 - Dec 2023
    Manager 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.
  • Cryo-Cell
    Executive Management Of Quality Department
    Cryo-Cell Jul 2014 - Jul 2022
    Responsible 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
  • Hoxworth Blood Center, University Of Cincinnati
    Quality Assurance Director For Cellular Therapies
    Hoxworth Blood Center, University Of Cincinnati Mar 2007 - Jul 2014
    Responsible 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.
  • Pedimed Pharmaceutical
    Senior Qa Associate
    Pedimed 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.
  • Alkermes
    Qa Associate
    Alkermes 2001 - 2005
    Ensure compliance to all quality SOPs.
  • University Of Cincinnati
    Research Assistant
    University Of Cincinnati Oct 1999 - Oct 2000
    Managed lab and performed experiments. Oversaw grant budget. Supervised student workers.

Andrea Darrow Skills

Quality Assurance Gmp Quality System Capa Change Control Pharmaceutical Industry Gxp 21 Cfr Part 11 Quality Control Validation Fda V&v Sop Glp Lims Biotechnology Medical Devices Good Laboratory Practice

Andrea Darrow Education Details

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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