20 years’ experience in the Biopharma industry; leadership positions in Global QA&QC and Compliance strategy. Focus on US, EU and global regulatory compliance and QA&QC in the GMP environment. Expert in 21 CFR Part 11 and technical vendor audits, validation, GAP analyses, risk assessment and risk management. Extensive team management capabilities, including a team of international auditors and CMC employees. Provide quality oversight of process validation and qualification activities for