CYRIL POSSA

• Sr. Director to Executive Director
• Led a cross-functional team of contractors and employees, providing comprehensive training and ongoing guidance to commission and validate a state-of-the-art 137,000sq/ft solid tumor aseptic GMP facility in just 15 months, exceeding industry standards
• Established and led a high-performing QA Computer System Validation team; validated critical systems, ensuring compliance with FDA regulations, and reducing potential compliance risks by over 50%
• Led the design and implementation of the Aseptic Process Validation requirements
• Led a successful QP and a Pre-Licensing Inspection (PLI) process with zero findings
• Led a risk-based validation efforts for a SalesForce based Chain of Identity/Chain of Custody project, achieving regulatory compliance, and streamlining processes
• Introduced a new eQMS (Master Control) for Change Control, Deviations and CAPA modules.

• Promoted from Director to Sr. Director
• Achieved a 35% increase in on-time closure of Corrective and Preventive Actions (CAPA), Change Control, and Deviations implementing process improvements and driving accountability
• Led the review and approval process for all validation lifecycle documentation, resulting in improved project outcomes and enhanced stakeholder confidence by ensuring compliance with cGMPs
• Implemented a new eQMS (Veeva) for Change Control, Deviations and CAPA modules

• Promoted from Sr. Consultant to Director
• Created a new Validation Department in the Engineering and Facilities Dept
• Setup the first Corporate Validation Master Plan for the Foster City Clinical Site
• Guided the Commissioning and Validation of a new Pharmaceutical Active Ingredient pilot plant facility
• Spearheaded the Commissioning and Validation of a QC Lab in Brazil, obtaining ANVISA approval within less than one year, facilitating market expansion in the region
• Directed requirements for SIA's and URS' to provide a Life Cycle approach in line with current cGMPs

• Brought in to lead teams through work plan deadlines for the consent decree
• Led the completion of 4 remediation steps which encompassed the Validation Life Cycle, Lab Equipment Qualification, Storage and Distribution, and Requalification programs, ensuring adherence to industry best practices and regulatory requirements
• Delivered all 4 remediation steps successfully against penalty related milestones agreed with FDA
• Collaborated with third party verifiers to complete in-place and in-use validation programs
• Executed gap assessments against new corporate standards to achieve verification by FDA representative.

• Promoted from Director to Sr. Director
• Directed the validation efforts for three pioneering immunotherapy facilities, spanning an impressive 120,000 sq ft each
• Derived risk appropriate quality assurance measures, resulting in flawless compliance and regulatory approval within the designated project timelines and budgetary parameters
• Achieved FDA Pre-Approval Inspection (PAI) for groundbreaking Immunotherapy Manufacturing Facilities in Morris Plains NJ, Atlanta GA, and Seal Beach CA, ensuring compliance and paving the way for life-saving treatments nationwide
• Streamlined the management of the Document Control department by implementing the Qumas Electronic Documentation System, resulting in a 20% reduction in review and approval time for remote teams
• Administered Compliance and Validation support to a BLA filing and a new facility Pre-Approval Inspection
• Collaborated with cross-functional teams to prepare for PAI and presented the Risk Assessment approach to FDA, leading to a favorable outcome and ensuring regulatory compliance
• Established the corporate Validation Department to support both internal and external validation systems and brought the facility up to the required compliance standards
• Led the validation efforts of electronic systems such as: ERP (Oracle), LIMS (LabWare), Calibration and Maintenance database (Maximo then transferred to Blue Mountain Regulatory Asset Management), a Document Management System (Qumas Edocs then transferred to Documentum) and a complex COI/COC system
• Qualified a new clean room and QC lab at the American Red Cross for a clinical Cell Processing Center
• Managed the Calibration program and Facilities after a major workforce reduction in 2007 for a year.

• Promoted from Associate Director to Director
• Staffed and developed a fully operational Validation and Metrology department
• Created a Computer Validation Master Plan and a road map for 21 CFR Part 11 compliance
• Assessed and validated the top10 highest risk software programs within the first 6 months to prepare for an FDA pre-approval inspection
• Initiated a software and equipment change control system
• Worked closely with IT on software life cycle to transition from development to validation to production environment
• Led the qualification and calibration programs for GLP labs
• Qualified and employed the use of Blue Mountain CalManager 4.0 to optimize calibration scheduling and filing

• Promoted from Validation Manager to Director of QA Technical Services
• Validation / Quality Engineering
• Spearheaded efforts to keep company compliant to all validation requirements including, equipment, process, cleaning, and computer validation
• Reduced operational deviations and implemented cost saving initiations
• Test Methods Development
• Developed and validated assays working closely with R&D, PD and QC
• Quality Systems Department
• Established and led a centralized validation department, providing end-to-end technical support to QA, Regulatory Affairs, Manufacturing, Facilities, and Engineering; streamlined validation processes, reducing time-to-market, and ensuring compliance with industry standards
• Reduced over 80% of outside consultant spending by implementing in house training and validation expertise
• Authored and implemented Quality Systems policies to increase compliance with FDA regulations and international regulatory bodies
• Initiated robust quality systems and processes, resulting in smooth FDA and TGA pre-approval inspections and achieving regulatory clearance for product commercialization
• Engineering Department
• Led and mentored consultants and project engineers to validate the new GMP facility on time and within budget
• Chaired company’s Change Control Board
• Specified and purchased process equipment including large-scale incubators and cryogenic equipment.