Sector Experience

Life Sciences & Pharma
17
years

Years of Experience

1/20

Member Since


Experience

 
Liontas & Assocuates Inc. Other
Independent Consultant
01/2012 - Present
Planning, executing and reporting of GCP (investigators, vendors, systems, processes) and GVP (sytems, processes, vendors, business partners) audits, in- process and qualification. Regulatory inspection preparation and support. Experience in North and South America and Europe, auditing systems against FDA, EMA and local regulations.

Scian Services Inc. Other
Consulting Director, Quality Assurance
10/2015 - Present
Overseeing quality program. Acting as the main resource for quality and compliance issues and responsible for further developing, implementing and maintaining the quality program.

Pfizer Inc. Other
Quality Assurance Professional - Vendor Audits
04/2011 - 11/2011
New York, NY
Applying quality assurance expertise to the auditing process. Leading, planning,
conducting and reporting of GCP vendor audits, Phase I to IV, on a global scale. Providing Quality and Compliance advice and feedback within various clinical programs

Hoffmann LaRoche Inc. Other
International Clinical Auditor
09/2008 - 03/2011
Nutley, NJ
Applying quality assurance expertise to the auditing process. Leading, planning,
conducting and reporting audits in Clinical Operations, Phase I to IV, and Pharmacovigilance, on a global scale, both internally and at investigator sites, contract organizations / vendors, and laboratories (Lead and Co Auditor)

Hoffmann LaRoche Ltd. Other
Drug Safety Specialist
01/2007 - 08/2008
Backup to Local Safety Responsible, collecting, processing and reporting to the local Health Authority domestic and foreign adverse events to marketed and investigational (bio)pharmaceuticals, liaising with health care professionals, consumers, Health Authorities and global counterparts to ensure the appropriate management and distribution of information globally and within regulatory timelines, responding to drug safety queries from HCPs, screening of Canadian literature, training of drug safet