Sarah Enwright Email & Phone Number

- Clinical site audits, vendors, CSV, and internal- QMS development and support- Assisting companies in implementing mobile technologies- Inspection readiness

GxP Auditing, Inspection Readiness, Quality Systems, Remote QA, Training

San Diego, Ca, Us

Primary Customer Success Role: - Provide leadership and subject matter expertise with respect to regulatory compliance and clinical practice - Educate and influence clients and partners on the most effective ways to implement the Clinical6 platform - Support the creation of user requirement documentation- Lead and support training course material design and delivery both internally and externally (e.g., clinical sites and investigator meetings) as needed.- Support custom integrations with clinical system to ensure final product meets customer requirements- Support customer during user acceptance testing cycleSecondary Quality Management Role: - Quality System Document management - Quality Incident (QI) management reporting and CAPA management- Supplier evaluation/audit and Internal Quality System audit- Lead client audits, and Coordinate audit responses and implementation of related CAPAs- Lead activities related to client regulatory inspections and regulatory inspections of P6- Fulfill requests related to the department’s business operations (e.g., metrics, status updates)

San Rafael, Ca, Us

Tokyo, Jp, Jp

• Manage audit program• Manage a team of consultants to conduct audits and co-audit as necessary.• Resource for Good Clinical Practices on clinical study teams• Support or host Regulatory inspections• Author/Revise R&D Compliance SOPs and develop and deliver GCP and lessons learned training

• Manage the external audit program (Clinical Investigator sites and R&D vendors).• Manage a team of consultants who conduct the audits and co-audit as necessary.• Resource for Good Clinical Practices on clinical study teams• Support or host Regulatory inspections• Author/Revise R&D Compliance SOPs and develop and deliver GCP and lessons learned training

• Authored SOPs for clinical quality audits, training, SOP development, documentation practices, and assisted in the revision of other departmental SOPs.• Develop and Deliver SOP and Good Clinical Practice (GCP) training.• Write audit plans, conduct or manage GCP site audits.• Write Statements of work and manage consultants.• Resource for Good Clinical Practices.• Trained in clinical trial monitoring

Authored SOPs for clinical quality audits, training, SOP development, documentation practices, and assisted in the revision of other departmental SOPs.Develop and Deliver SOP and Good Clinical Practice (GCP) training.Write audit plans, conduct or manage GCP site audits.Resource for Good Clinical Practices.Trained in clinical trial monitoring.

Created and maintained IT projects.

• Created and maintained IT project schedules

Us

needed to relocated for personal reasons, references available) Managed several new drug candidates through development process to approval for commercial use.

Liaison between Facilities and Engineering group and Manufacturing. Produced and maintained an accurate production schedule including preventative and corrective maintenance work using both Microsoft Project and Werum Pasx.

Maintained constant supply of mammalian cell culture for the manufacture of a biologic macromolecule. Maintained the quality of the process by initiating and owning non-conformances using the Trackwise system. Assisted in investigations of non-conformances. Maintained GMP documentation by reviewing and revising manufacturing batch records, and SOPs.

Lead Wave Bioreactor project team of 8 members to begin the design of a new cell culture scale-up process using the Wave Bioreactor system. As active team member, successfully performed technology transfer of new cell culture scale-up process to manufacturing.

Ms, Clinical Research Organization And Management

Bachelors Of Science, Biology