Oscar Sanchez

Vice President of Quality and Regulatory Affairs

Oscar Sanchez is a results-driven Vice President of Quality and Regulatory Affairs with over 30 years of executive leadership in pharmaceuticals, biologics, and medical devices. He excels at building robust quality systems, securing regulatory approvals, and delivering flawless FDA and global inspections across complex manufacturing environments.

Key Highlights in Pharma & Medical Device Quality

• Led quality operations for global sites producing small molecules, biologics, cell/gene therapy, aseptic fill/finish, solid dosage, and drug-device combinations.
• Secured approvals for 6 NDAs, 8 INDs, 3 BLAs, 5 PMAs, and 21 510(k)s (including SaMD and companion diagnostics).
• Achieved zero warning letters across 360+ FDA inspections (including PAIs, BIMOs) and 200+ global audits (EMA, PMDA, APAC, Latin America).
• Successfully remediated multiple sites under FDA scrutiny, resulting in PAI approvals and product relaunches (e.g., $1.4B product at Novartis).
• Directed GLP-certified animal labs/vivariums and clinical quality for 20+ trials with zero observations in FDA BIMO inspections.
• Supported major acquisitions, including Reata Pharmaceuticals ($6.5B Biogen deal) after NDA approval.

A U.S. Navy Nuclear Engineer veteran and Six Sigma Master Black Belt, Oscar is known for turning around underperforming operations, reducing complaints and defects, and implementing enterprise-wide QMS that drive compliance and efficiency.