Beatriz Velasco-Taboada Email & Phone Number

Emeryville, California, United States

Emeryville, California, United States

Brisbane, Ca

Quality Assurance Functional Manager on the Early Development programs, providing Quality oversight of cGMP operations performed at Aimmune Contract Manufacturing Organizations and Contract Testing Labs per U.S. and global requirements. Conduct internal/external audits, participate in inspection readiness activities, and provide assistance in regulatory filings. Provide Quality related decisions and guidance to project teams.

Novato, California

Novato, California

South San Francisco

• Review and verify assigned Process Characterization & Validation (PC/PV) study packages for accuracy, clarity, completeness and traceability; including sign off of the supporting data tables.• Flag errors or unclear portions in PC/PV packages, including the supporting raw data.• Compile a list of findings and complete the compliance verification form.• Follow applicable procedures, Quality Standards, Quality Policies and comply with industry guidelines and cGMPs as appropriate.• Communicate effectively with PVSD and administrative support within the group.

South San Francisco

• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.• Provide technical review and approval of validation deliverables for drug substance and drug product process validation and characterization, ensuring proper study design and execution.• Develop solutions to complex Quality Engineering and Validation issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards.• Provide technical assessment and approval of process changes.• Represent the department on relevant project teams.

South San Francisco

• Perform cumulative review and disposition of Genentech manufactured cell banks, clinical drug substance, drug product and final drug product.• Perform review of deviations, investigations, QC assay variances, and anomalous results associated with batch records to ensure that they are complete, accurate and defendable.• Review and approve procedures, tickets and applicable clinical QA controlled documentation.• Provide clinical support such as COA/COC/COT requests, reconditioning authorizations, extension dating, label artwork approvals, CRC sign-off and support of clinical campaigns.• Serve as Quality Assurance Lot Disposition representative for sub-CMC teams, QPS, Supply Chain and GSET meetings.• Gather, provide and present metrics data for Clinical QA Lot Disposition to upper management and various departments.• Supervise 3 direct reports by providing support, guidance and development opportunities and ensuring their goals are aligned with departmental and company goals.• Provide training to personnel and other departments on Quality Lot Disposition procedures.• Exert influence in the development of objectives and long range goals of the organization.• Make independent decisions around highly complex issues in alignment with GNE policies.• Identify, lead and implement process improvements.

South San Francisco

• Perform review of deviations, investigations, QC assay variances, and anomalous results associated with the labeling/packaging, final vial and bulk Batch History Records (BHR) to evaluate cumulative effect prior to disposition.• Provide support during regulatory inspections.• Key point of contact for all Quality issues affecting lot disposition of Pulmozyme, Activase and TNKase.• Manage the planning and execution of lot disposition activities to support the review and release of my assigned products, in accordance with regulatory requirements, cGMP's and Genentech policies and procedures.• Interact with multiple business units to assure all lot disposition issues are identified and resolved in a timely manner.• Interact with Manufacturing Quality Assurance (MQA) managers to ensure discrepancies and investigations are resolved in order to meet standard lead times for product disposition.• Interact with QA Lot Disposition Supervisors and Associates to ensure that all issues discovered during final review are resolved to meet standard lead times for product disposition.• Serve on project teams to influence the effectiveness of meetings based on knowledge of quality requirements, industry standards and company strategy.• Communicate to QA senior management any potentially significant quality issues.• Represent the QA Lot Disposition department at inventory and planning meetings.• Monitor and manage efforts to ensure continuous improvements to procedures, processes and systems.

South San Francisco

• Perform cumulative review and approval of all labeling/packaging batch history records.• Perform cumulative review and approval of bulk and final vial batch history records.• Attend weekly packaging inventory meetings and senior staff meetings and report relevant information to appropriate personnel.• Oversee the labeling/packaging final review process.• Provide Quality label/pack assessment of product complaints.• Generate expiration dating extension letters and created the expiration dating extension letter SOP.• Enhance lot release procedures through SOP revisions and creation of guidance documentation.• QA representative for the ACRS+.