Sandy Cascone
Arnold,MO
Summary
20+ years of experience in pharmaceutical development / ICH-GCP with an emphasis in Quality Assurance, Compliance and Operations. Extensive working knowledge of International Council on Harmonisation/Good Clinical Practices and FDA Regulations pertaining to clinical development. Hosted FDA inspections Experienced in System Auditing, Vendor Selection and Qualification, and SOP Development. Leader / initiator to develop processes supporting Issue Management/Quality Systems/ CAPA
Overview
26
26
years of professional experience
Work History
Director, Quality Assurance (US)
Symbio Research
10.2023 - Current
- Supervisory responsibilities
- Hosted FDA Inspections and Client Audits
- Lead process improvement initiatives related to compliance
- Supported the QMS development during merger with new EU company
- Managed Audit oversight, CAPA processing
- Conduct audits externally as needed
- Conducted investigations relating to Scientific Misconduct and Serious GCP Non-Compliance
- Reviewed / Approved documents Clinical Study Reports prior to submission
- Managed triennial revision cycle for SOP Suite for all functional departments
- Provided ICH/GCP guidance, auditing guidance and training to internal and external customers
Quality and Compliance Sr. Manager
Precision Medicine Group
10.2016 - 08.2023
- Supervisory responsibilities for 5 direct reports
- Lead process improvement initiatives related to compliance.
- Supported the QMS development: Procedures/ CAPA
- Initiated, conducted, and monitored CAPA for internal system / Trial Master File audits.
- Supported / collaborated with all internal teams (e.g., Projects Teams, Clinical Trial Operations) and external partners (e.g., Vendors / CRO) in an auditing and/or consultancy basis.
- Coordination and management of regulatory inspection support
- Conducted investigations of relating to Scientific Misconduct and Serious GCP Non-Compliance
- Supported the enhancement of Corporate Compliance regarding Training processes, systems and management of quality issues
- Reviewed documents intended for submission to the FDA to assure compliance with regulatory standards.
- Developed Quality Standard Operating Procedures
- Managed triennial revision cycle for SOP Suite for 8 functional departments (including Clinical Operations, Safety and Data Management)
- Trained staff on CAPA process and system
- Perform ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations.
- Provide ICH/GCP guidance, auditing advice and training to internal and external customers
- Managed Quality Systems for procedures, training and CAPA management
- Provided procedural and systems training to staff
Manager, Quality Assurance
United BioSource Corporation
10.2008 - 10.2016
- Managed internal QA audit function to ensure compliance with company standard operating procedures and Good Clinical Practices (GCP) guidelines.
- Audited and assisted in managing external audit functions (vendors, subcontractors).
- Providing document QA services to the Medical Writing and Regulatory Operations group
- CAPA management Quality point of contact for procedural requirements and system development
- Supported / hosted client audits
- Audited Computer System Validation documentation.
- QA support to Pharmacovigilance, Biometrics, Clinical Operations
- Reviews project plans relating to UBC services
- QA support during regulatory inspections at client sites
Internal Quality Senior Manager
DynPort Vaccine Company, LLC (a CSC Company)
01.2005 - 01.2008
- Supervised 2 direct reports – Quality Specialist and Quality IT applications SME
- Monitored Compliance to applicable FDA regulations and internal standards (Departments responsible for Product Quality, Clinical Quality, Business Quality, Program Management)
- Managed CAPA, audit schedules, investigations and process improvement plans
- Reviewed all documentation prior to delivering to Customer (included RFPs, audit responses)
- Developed, Reviewed and Approved SOPs
- Qualified software vendors per qualification processes
- Training - mentoring new employees
- Prepared GLP/ISO 17025 Quality Manual for Novartis, Sweden
- Engaged in oversight of American Red Cross while under FDA consent decree
- Performed work with corporate transition team for the American Red Cross (ARC)-Computer Server move to Chicago Data Center.
- Ensured compliance with regulations (Qualification of Infrastructure, Training, Auditing) as directed by Program Manager.
- Conducted internal audits to ensure compliance to ARC IT procedures.
Associate QA Manager, Drug Delivery Division, R&D
West Pharmaceutical Services, Inc.
01.2002 - 01.2005
- Conducted internal/external audits for compliance to GMP, GCP, GLP and IPEC
- Qualified vendors - software, drug product components
- Conducted GCP training for Drug Delivery staff.
- Prepared SOPs and policies for Quality Assurance Department (which included the UK West Pharmaceutical Drug Delivery division)
- Quality oversight during manufacture of generic drug – manufacturing site
- Reviewed documentation associated with release of clinical supply materials
- Reviewed/approved facility qualification documentation (IOPQ and protocols)
- Conducted QC data audits for toxicology studies/ GLP
- Provided oversight and developed a secondary packaging operation for drug product
- Involved in clinical quality assurance documentation reviews for ANDA submission.
Quality Manager
Genaera Corporation
01.2000 - 01.2002
- Manager of the Quality Assurance Department, responsible for the establishment of Quality systems, with applicable regulatory (GMP, GCP, GLP) supporting clinical supply manufacture for Phase 1/2 clinical material.
- Conducted internal and external audits (included audits of clinical manufacturing vendors)
- Provided CGMP training to research and development personnel.
- Reviewed Batch records for Research and Development and Contract Manufacturing.
- Prepared, reviewed, and updated internal documentation and procedures.
- Maintained CAPA system, initiated process improvements.
- Conducted internal issue investigations as needed.
- Special Project: Kilo Laboratory Oversight. Provided guidance, reviewed procedures, batch records, equipment qualification.
Education
Bachelor of Science - Biology (Minor in Chemistry)
McKendree University
Lebanon, ILCoursework - QA/RA Program
Temple University
Philadelphia, PASkills
- Strong interpersonal skills
- Collaborative strategic planning
- Effective verbal communication
- Collaborative decision-making
Timeline
Director, Quality Assurance (US)
Symbio Research
10.2023 - Current
Quality and Compliance Sr. Manager
Precision Medicine Group
10.2016 - 08.2023
Manager, Quality Assurance
United BioSource Corporation
10.2008 - 10.2016
Internal Quality Senior Manager
DynPort Vaccine Company, LLC (a CSC Company)
01.2005 - 01.2008
Associate QA Manager, Drug Delivery Division, R&D
West Pharmaceutical Services, Inc.
01.2002 - 01.2005
Quality Manager
Genaera Corporation
01.2000 - 01.2002
Coursework - QA/RA Program
Temple University
Bachelor of Science - Biology (Minor in Chemistry)
McKendree University