Patrick Deming Email & Phone Number

College Station, Tx, Us

Fallbrook, Ca, Us

Billingham, Gb

Providing Quality Assurance oversight ensuring capital projects meet Genentech's validation program regulatory and procedural requirements as related to manufacturing equipment, facilities, utilities and automated systems . Primary duties include: Managing QEV project budgets, contractor staff and systems validation work in support of capital projects (purification expansion) .

Provided Quality Assurance oversight for the Change Control program. Developed site-specific change control strategies in accordance with requirements defined in global standard procedures to support commercial, clinical operations and Technology transfers. Managed up to 8 direct reports.Primary duties included:• Head of Local Change Control (local oversight of global change execution)• Participated in Global Change Control team meetings and initiatives• Team Lead: Local Change Control Triage• Developed change control strategies for technical product transfer and NPI• Successfully implemented PQS rollout of local and global change control programs• Presented change control program during regulatory inspections

Provided Quality Assurance oversight to the validation program and managed QA validation staff. Primary duties included:• Ensuring Automation Systems validation meets regulatory and procedural requirements• Reviewed and approved automation validation, specifications, protocols and reports (includes Automation, Equipment, Facilities, Utilities, Cleaning)• Resource planning and management for technical transfer projects• Reviewed and approved Process Validation supporting Avastin transferOther duties include: Presented during regulatory inspections as necessary. Identify and resolve validation GMP issues. Wrote direct reports performance management appraisals.