Alena Galante

Education

• Certification Seton Hall University School of Law (2009 — 2009)
• Certification Kaplan University (2008 — 2009)
• MBA Fairleigh Dickinson University (1998 — 2003)
• Bachelors of Science New Jersey Institute of Technology (1982 — 1987)

Companies

• Director, Quality & Compliance Diligent Health Solutions (2021)
• President Galante Compliance Services, LLC (2008)
• President Galante Compliance Services, LLC (2008)
• Part Time Lecturer Rutgers Business School (2020 — 2020)
• Adjunct Professor - Graduate Studies Fairleigh Dickinson University Silberman College of Business (2017 — 2017)
• Director, Consumer Affairs Johnson & Johnson Group of Consumer Companies (Pfizer Consumer Healthcare) (2006 — 2007)
• Director, Regulatory Compliance & Quality Pfizer (2003 — 2006)
• Director, Corporate Validation Pfizer (Warner-Lambert) (1998 — 2003)
• Manager, Validation Organon (1990 — 1998)

Skills

• Manufacturing
• Regulatory Affairs
• ISO

Other

Design Control, Technology Transfer, SOP, U.S. Food and Drug Administration (FDA), Medical Devices, Regulatory Submissions, Pharmaceutics, Change Control, Quality System, Computer System Validation, Leadership, Quality Control, 21 CFR Part 11, CAPA, Quality Assurance, Pharmaceutical Industry, GMP, Validation, FDA