Cyril Possa
San Mateo,CA
Summary
Accomplished Quality leader recognized for successfully collaborating with management and stakeholders to develop Quality programs compliant with regulations.
Work experience includes Aseptic Manufacturing, Cell Culture, Tissue Engineering, and Autologous Immunotherapy in CGT. Delivered outstanding results with 6 successful Pre-Approval Inspections, propelling 4 first-in-class biotech products to market with the ability to balance compliance requirements and business needs.
Overview
33
33
years of professional experience
Work History
Executive Director of QA Technical Services & Compliance
Iovance Biotherapeutics
08.2019 - 11.2023
- Promoted from Sr Director to Executive Director
- Led 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
- Led successful QP and Pre-Licensing Inspection (PLI) process with zero findings
- Implemented new eQMS (Master Control) for Change Control, Deviations and CAPA modules
- 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 Aseptic Process Validation requirements
- Established risk-based validation efforts for a SalesForce based Chain of Identity/Chain of Custody project, achieving regulatory compliance, and streamlining processes.
Senior Director of Quality System and Validation
Intarcia Therapeutics
06.2017 - 08.2019
- Promoted from Director to Sr Director
- Implemented a new eQMS (Veeva) for Change Control, Deviations and CAPA modules
- Achieved 35% increase in on-time closure of Corrective and Preventive Actions (CAPA), Change Control, and Deviations implementing process improvements and driving accountability
- Led review and approval processes for all validation lifecycle documentation, resulting in improved project outcomes and enhanced stakeholder confidence by ensuring compliance with cGMPs.
Director of Validation
Gilead Sciences
02.2015 - 04.2017
- Promoted from Sr Consultant to Director
- Created new Validation Department in the Engineering and Facilities Dept
- Setup the first Corporate Validation Master Plan for the Foster City Clinical Site
- Guided Commissioning and Validation of a new Pharmaceutical Active Ingredient pilot plant facility
- Directed requirements for SIA's and URS' to provide a Life Cycle approach in line with current cGMPs
- Spearheaded Commissioning and Validation of a QC Lab in Brazil, obtaining ANVISA approval within less than one year, facilitating market expansion in the region.
Director of QA
Genzyme (a Sanofi Company)
01.2012 - 08.2014
- Brought in to lead teams through work plan deadlines for the consent decree
- Led the completion of 4 remediation steps which encompassed Validation Life Cycle, Lab Equipment Qualification, Storage and Distribution, and Re-qualification 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.
Senior Director, QA Compliance & Validation
Dendreon Corporation
03.2004 - 09.2011
- Promoted from Director to Sr Director
- Directed 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 designated project timelines and budgetary parameters
- Administered Compliance and Validation support to BLA filing and new facility Pre-Approval Inspection
- Collaborated with cross-functional teams to prepare for PAI and presented the Risk Assessment approach to FDA, leading to favorable outcome and ensuring regulatory compliance
- Established the corporate Validation Department to support both internal and external validation systems and brought facility up to required compliance standards
- Led validation efforts of electronic systems such as: ERP (Oracle), LIMS (LabWare), Calibration and Maintenance database (Maximo then transferred to Blue Mountain Regulatory Asset Management), 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
- 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 way for life-saving treatments nationwide
- Streamlined management of Document Control department by implementing Qumas Electronic Documentation System, resulting in 20% reduction in review and approval time for remote teams
- Managed the Calibration program and Facilities after a major workforce reduction in 2007 for a year.
Director, Validation & Metrology
Amylin Pharmaceuticals Inc
10.2002 - 03.2004
- 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
- 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
- Initiated a software and equipment change control system
- Qualified and employed the use of Blue Mountain CalManager 4.0 to optimize calibration scheduling and filing.
Director of QA Technical Services & Compliance
Advanced Tissue Sciences
04.1997 - 10.2002
- Promoted from Validation Manager to Director of QA Technical Services
- Developed and validated assays working closely with R&D, PD and QC
- 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
- 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
- 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.
Validation Supervisor
Collagen Corporation
01.1995 - 01.1997
Validation Engineer
Hoffman - La Roche
01.1994 - 01.1995
Process Validation Engineer II
Organon Pharmaceuticals
01.1991 - 01.1994
Education
Master of Science - Engineering Management
New Jersey Institute of Technology
Newark, NJ05.1996
Bachelor of Science - Electrical Engineering
New Jersey Institute of Technology
Newark, NJ05.1991
Skills
- Leadership Clinical to Commercialization
- Aseptic Process Validation
- Quality Systems Compliance Remediation
- Pre-Approval Inspection
- Validation & Commissioning
- Risk Based Approach
- Metrology
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Executive Director of QA Technical Services & Compliance
Iovance Biotherapeutics
08.2019 - 11.2023
Senior Director of Quality System and Validation
Intarcia Therapeutics
06.2017 - 08.2019
Director of Validation
Gilead Sciences
02.2015 - 04.2017
Director of QA
Genzyme (a Sanofi Company)
01.2012 - 08.2014
Senior Director, QA Compliance & Validation
Dendreon Corporation
03.2004 - 09.2011
Director, Validation & Metrology
Amylin Pharmaceuticals Inc
10.2002 - 03.2004
Director of QA Technical Services & Compliance
Advanced Tissue Sciences
04.1997 - 10.2002
Validation Supervisor
Collagen Corporation
01.1995 - 01.1997
Validation Engineer
Hoffman - La Roche
01.1994 - 01.1995
Process Validation Engineer II
Organon Pharmaceuticals
01.1991 - 01.1994
Master of Science - Engineering Management
New Jersey Institute of Technology
Bachelor of Science - Electrical Engineering
New Jersey Institute of Technology
Accomplishments
- Achieved successful FDA approvals for Advanced Tissue Sciences, Dendreon, and Iovance Biotherapeutics facilities.
- Received ANVISA approval for a new Gilead QC site in Brazil.
- Managed the process validation for Dendreon at PharmaCell in the Netherlands and the American Red Cross in Philadelphia, PA.
- Overhauled both Intarcia Therapeutics and Iovance Biotherapeutics from a paper QMS to an electronic solution.
Languages
English, French
Native language