Cyril Possa
San Mateo,CA
Summary
QUALITY AND VALIDATION PROFESSIONAL Pharmaceutical ~ Biotech ~ Medical Device Accomplished Quality Professional with over 30 years of experience. Work experience includes Aseptic Manufacturing, Solid Dosage, Biotech, Medical Devices, Cell Culture, Tissue Engineering and Immunotherapy. Over 10 years of experience with Cell and Gene Therapy Strong expertise in cGMP, Quality Systems, Quality Engineering and Validation. 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. Versatile Executive Director focused on promoting mission and increasing effectiveness of key programs. Passionate about managing and overseeing implementation of company's daily operations. Quick and firm decision-maker possessing first-rate communication and organizational skills. Recognized for successfully collaborating with management to develop work plans, financials and strategies.
Overview
26
26
years of professional experience
Work History
Executive Director of QA Technical Services
Iovance Biotherapeutics
01.2019 - 01.2023
- Promoted from 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.
Senior Director of Quality System and Validation
Intarcia Therapeutics
01.2017 - 01.2019
- Promoted from Director to Sr
- Director
- Achieved a 35% increase in on-time closure of Corrective and Preventive Actions (CAPA), Change Control, and Deviations as leader of the Quality System department, 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.
Director of Validation
Gilead Sciences
01.2014 - 01.2017
- 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.
Director of QA
Genzyme (a Sanofi Company)
01.2012 - 01.2014
- 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.
Senior Director, QA Compliance & Validation
Dendreon Corporation
01.2004 - 01.2011
- 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.
Director, Validation & Metrology
Amylin Pharmaceuticals Inc.
01.2002 - 01.2004
- 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
- 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.
Director, QA Technical Services
Advanced Tissue Sciences
01.1997 - 01.2002
- Promoted from Validation Manager to Director of QA Technical Services
- 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
- Developed and validated assays working closely with R&D, PD and QC
- 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
- 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.
Education
Master of Science in Engineering Management -
New Jersey Institute of Technology
Bachelor of Science in Electrical Engineering - undefined
New Jersey Institute of Technology
Skills
- Leadership
- Quality Systems
- Validation & Commissioning
- Clinical to Commercialization
- Compliance Remediation
- Risk Based Approach
- Aseptic Process Validation
- Pre-Approval Inspections
- Calibration
Affiliations
- The International Society for Pharmaceutical Engineering (ISPE)
- The Parenteral Drug Association (PDA)
- The Institute of Validation Technology (IVT)
Languages
French
Native or Bilingual
Timeline
Executive Director of QA Technical Services
Iovance Biotherapeutics
01.2019 - 01.2023
Senior Director of Quality System and Validation
Intarcia Therapeutics
01.2017 - 01.2019
Director of Validation
Gilead Sciences
01.2014 - 01.2017
Director of QA
Genzyme (a Sanofi Company)
01.2012 - 01.2014
Senior Director, QA Compliance & Validation
Dendreon Corporation
01.2004 - 01.2011
Director, Validation & Metrology
Amylin Pharmaceuticals Inc.
01.2002 - 01.2004
Director, QA Technical Services
Advanced Tissue Sciences
01.1997 - 01.2002
Master of Science in Engineering Management -
New Jersey Institute of Technology
Bachelor of Science in Electrical Engineering - undefined
New Jersey Institute of Technology
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