View my background, experience and leadership skills in addition to my resume.

1. Cyril Possa
Quality Assurance and Validation Professional
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2. Introduction and Education
Born and raised in
Switzerland until age
15
Native language -
French
BS in Electrical Engineering
Completed my MS in Engineering
Management at night
2 Full Time Internships:
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3. Professional Work History
The Early Years
Started my career as a Validation Engineer in Mid size and Big Pharma, where I
learned the Quality Systems basics.
Validation Engineer I
Validation Engineer II
Validation Engineer
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• Sterilization
• Depyrogenation
• Aseptic Manufacturing • Computer Validation
• Clinical Packaging
• Solid dosage

4. Professional Work History
California Part 1
Sr. Val. Engineer
Validation Supervisor
Validation Manager
Director, Quality Technical Services
Assoc. Dir. Val. & Metrology
Director Val. & Metrology
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• CFR 820 Medical Devices
• Change Control Management
• Supervision of staff and contractors
• Tissue Engineering
• Quality Engineering
• Shipping and Storage Validation
• Passed Audits from TSA and FDA
• Successful PAI for 2 products (Trancyte
& Dermagraft)
• Computer Software Validation
• Metrology
• Dept. Doc. Control

5. Professional Work History
Seattle and Boston
Director, Validation
Sr. Director, Corporate Validation
Director, QA Validation
(Office of Consent Decree)
• Immunotherapy
• Managed Documentation Control
• Support Cold Chain for both cryogenic and
2-8C products
• Successfully qualified 3 clinical facilities
and 3 commercial facilities
• Qualified complex chain of identity process
from patient back to patient
• Assessed Change Controls and CAPA’s
based on compliance and risk assessment
• Successfully delivered remediation steps
per FDA mandate
a. Validation Life Cycle
b. Lab Equipment Qualification
c. Storage and Distribution
d. Requalification
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6. Professional Work History
California Part 2
Director, Validation
(Facilities and Engineering
Department)
• Authored the first Foster City, CA Validation
Master Plan
• Successfully commissioned and qualified a
new Pilot Plant
• Implemented the concept of using GDP early
on during FAT and Commissioning to
leverage and minimize redundancy during
qualification
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7. Professional Work History
International
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• Responsible for preparing a small
QC lab in Brazil compliant and
approved by ANVISA
• Establish a documentation system to
sustain an inspection
• Site was audited by ANVISA and the
company was given approval to sell
in the country
• Responsible for qualifying a CRO for
European clinical trials
• Worked closely with the site QP
• Facility successfully produced
clinical material
Netherlands Brazil

8. Communication & Mgmt Style
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9. Communication & Mgmt Style
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OPEN DOOR POLICY

10. Communication & Mgmt Style
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11. Communication & Mgmt Style
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LEAD BY
EXAMPLE
COMMUNICATE

12. Successful Project Example
GOAL:
Preparing 3 Commercial Facilities for Pre-Approval Inspection of the first US
Oncology Immunotherapy.
STATEGY:
• Developed a plan that was efficient, scalable, transferable and compliant
between Seattle, WA and Morristown, NJ
• Focused on high risk items and especially product cold chain management.
• Developed non-location specific procedures for flexibility.
• Required standardization of equipment at all sites.
• Transferred lessons learned from site to site.
• Communication with all sites was crucial to assure that one site would not
accidently place other sites at compliance risk.
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OUTCOME:

13. QUICK HIGHLIGHTS
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 BS & MS in Engineering
 Over 25 years of experience in Biotech, Pharma & Medical
Devices
 Strong Aseptic and CSV background
 Successfully managed Doc. Control, Change Control, Quality
Engineering, Metrology and Validation
 Contributor in 5 successful PAI
 Quickly adapted to many different sciences
 Good Employee and Leader, Promoted at 4 of my last 6
companies