Francesca (Fran) Mayo Email & Phone Number

United States

• Achieved successful launch of Adobe Acrobat Sign 21 CFR Part 11 ERES application for use by clinical and medical research scientists. Directed and performed the
• establishment of business work flows to ensure deployment,
• activities required for validation lifecycle,
• review and approval of system related documents,
• generation of training requirements and
• drafting of site wide notifications for launch.

Drive quality and consistency across site validation activities, systems, procedures, and processes for a pharmaceutical and dermatological product manufacturing company. Oversee team of 8 staff to support validation efforts with leadership over contracted personnel managing validation or qualification of equipment and systems. Participate in internal and.

CAR-T Apheresis Collection Site ProjectServe as a project point person in support of vendor quality qualification and patient operations in the conversion of clinical apheresis sites to commercial operations to ensure on-boarding is performed Right-the-First-Time

Bothell, Washington, US

Advanced site Quality metrics program by performing process mapping and gap analyses, authoring life-cycle and site operational procedures. and corroborating with staff on continual improvement opportunities.

Project responsibilities included industry trending research, service and business process analyses, and preparation and revision of report summary`s

Paris, France, FR

Provided quality compliance support to biopharma production and ancillary operations to ensure the overall quality of the deviation management process and procedures, i.e., investigations and delivered solutions including change management, were in alignment with business and regulatory expectations. Additionally, supported Risk Management,activities, FMEA.

South San Francisco, California, US

Kelly Scientific, Inc. - Sr. ConsultantAdverse events and technical complaints associated with clinical and commercial products.

South San Francisco, California, US

Versa Engineering, Inc. - Sr. ConsultantReturn-to-Service (RTS) CCP2 Project Member - Performed activities in support of equipment and process re-qualification efforts

• Aerotek Scientific, Inc. Sr. Consultant
• Reconciliation of a Device History File (DHF) in support of DHF inspection readiness. Gap analysis of IVD shipping validation studies.

Foster City, CA, US

• AdeptSource, Inc. Sr. Principle Consultant
• Computerized System Quality Remediation and Compliance Analysis - Elimination of discrepancy backlog, investigation of new incidents, development and implementation of reengineered investigation resolution process. New.
• Sparta Systems Trackwise Development and Implementation – Beta testing of Trackwise QMS modules and SOP generation.
• Gap analysis of laboratory OOS investigation records in support of PAI.

South San Francisco, California, US

• Validant, Inc - Sr. Consultant
• QAV Risk Management and Remediation - Generation of RA`s related to downstream, legacybiopharma manufacturing equipment.

Leverkusen, North Rhine-Westphalia, DE

• While in tenure at Bayer HealthCare,
• Manager of QAV staff and contractors
• Established site policies pertaining to validation
• Critiqued Quality Compliance procedures for international, domestic and corporate regulatory gaps
• Provided project management expertise for validation project activities
• Reengineered Quality practices to eliminate non-value added process steps and paperwork

Emeryville, California, US

• Lead Validation team member on technology transfer projects and contract manufacturing project teams.
• Managed and performed validation activities and change control documentation review and approval related to the equipment, facility and utilities and processes used in the fermentation and purification suites for the.
• Hired and managed contract validation personnel.
• Provided compliance, validation and project management CMO support to clients. Activities resulted in successful production of clinical material.

• Management of the validation program plan at the European bulk drug API CMO facility in preparation for the pre-approval inspection (PAI). Activities resulted in successful licensing of the facility.
• Served as the validation and quality assurance liaison between COR Therapeutics, Inc. and foreign and domestic CMOs under contract to COR. Ensured firms operated in compliance with the applicable regulations and.