Michelle Whitaker Email and Phone Number

Assures compliance and quality processes are maintained in support of clinical trial operational activities. Quality leadership responsibilities include: critical client audits and issues management, critical vendor management, regulatory and quality compliance advisory and SME contribution to key strategic initiatives, contract management, gap analyses, validation, auditing, training and project management of key strategic improvements.

Assured compliance and quality processes are maintained in support of clinical trial operational activities, served as quality assurance advisor on select strategic projects, provided quality and regulatory advisement.

Ensured compliance and quality processes were maintained in clinical trial operational activities, provided internal regulatory advisement, and managed quality assurance team.

Ensured compliance and quality processes were maintained in clinical trial operational activities, and supervised quality assurance team.

Processed payroll and new hire onboarding, served as primary administrator for the organization's learning management software, and was responsible for aligning Training programs and systems with organization strategic development while adhering to regulatory requirements.

Performed Quality Assurance tasks including: change management, document control, internal audits, vendor audits, non-conformance reporting management, QA review of IT validation documentation, and process efficiency projects.

Conducted quality and regulatory trainings for all operational areas, performed document control and change management activities.

Cross-functional role responsible for all quality assurance activities and served as on-site human resources contact.

Responsible for all quality assurance activities: document control, change management, non-conformance reporting management, internal audits, vendor audits, hosting client audits, document retention/archiving, quality and regulatory training, QA review of IT validation documentation, and advisement to Executive Management on quality and regulatory topics.