William Senatore

About William Senatore

I have diverse experience in Project Management across the pharmaceutical industry. I am a Lean Six Sigma Kaizen Leader and led a project to reduce medication waste. I am a well respected Manager of my teams. My career at Pentec Health provided me the opportunity to become a well rounded Pharmacist and expand my expertise. Starting as a Specialty Infusion Pharmacist, I became adept in sterile compounding, pain management clinical consultation, and USP 797. I was promoted to a Supervising Production Pharmacist within the company\'s new 503B Sterile Injectable Outsourcing Facility. I gained knowledge of Current Good Manufacturing Practices (cGMP), USP 800, and managed a team of professionals. Less than a year later, I was promoted to Head of Production/Pharmacist-in-Charge. In this role, I developed expertise in Deviation and Investigation writing, Change Control, Corrective and Preventative Action (CAPA) Implementation, Equipment Validation, Product Development, and Production Planning. I have assisted in Regulatory Inspections as a Subject Matter Expert for the FDA, DEA, and States Boards of Pharmacy. I believe taking care of patients is a multi-disciplinary job. I am an Adjunct Professor of Advanced Pharmacology at Wilkes University. In this position, I have the privilege of teaching Pharmacology to Nursing Professionals. This relationship allows us to expand the team available to provide clinical care for our patients. I have also co-authored a journal article with a colleague which is published in a Nurse Practitioner Magazine.

Experience

1. Senior Director, Quality Assurance - Medical Device and Pharmaceuticals

   CooperSurgical

   Jan 2024 — Present

   Management/Leadership:Manage and provide support to the Site Heads of Quality Assurance and Pharmacovigilance Manager for Pharmaceutical and Medical Device manufacturing facilities.Hire, develop, coach, and ensure the growth of Quality Assurance and Pharmacovigilance personnel.Serve as a leader of cross-functional teams for key company-wide projects. Build and maintain a culture of continuous quality improvement. Perform performance reviews for direct reports.Cross-Functional Collaboration:Work with multidisciplinary leadership to ensure the site Quality Management Systems (QMS) for each site are designed and operating in compliance with applicable Federal, State, and local regulations. Co-lead a team to standardize and harmonize Quality Management Systems across the organization.Collaborate with multidisciplinary Senior Leadership and Executive Leadership Teams to escalate issues and serve as a subject matter expert to provide risk mitigation science-based solutions.Work with a multidisciplinary team to achieve approval of a Supplemental New Drug Application.Work with pharmacovigilance and medical information providers to ensure compliance and timely reporting of adverse event cases and product complaints.Compliance:Host and participate in FDA, TGA, EMEA, and other regulatory authority inspections across multiple sites.Ensure site readiness for both internal and external audits. Ensure timely reporting of individual case safety reports (ICSRs).Develop, review, and maintain key performance indicators (KPI) and investigate any out of trend results.Serve as 21 CFR 210 and 211, 21 CFR 820, and ISO 13485 subject matter expert for the company. Ensure DSCSA Compliance across all sites.

Education

• Temple University

  Pre-Pharmacy, Pharmacy

  2001 — 2003

• Temple University

  Doctor of Pharmacy - PharmD, Pharmacy

  2003 — 2007

Skills

• Medication Therapy Management
• Pharmacy
• Pharmacists
• Pharmacy Automation